FDA · Medical device recall

Atec Insignia Anterior Cervical Plate System… and 28 more products

June 16, 2021 Class II

Date: June 16, 2021
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Terminated
Filed by: Alphatec Spine, Inc.
Reason: There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
Distribution pattern: US Nationwide distribution in the states of FL, CA, IL, OK, TX, CT, IN, NC, WA, HI, ID, MA, SC, NM, and NY.

29 products in this recall

Atec Insignia Anterior Cervical Plate System…

Product: Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI: (01)00190376268422
Quantity: 8 units
Codes and lots: 8609301R
Recall started: April 26, 2021
Device type: Appliance, Fixation, Spinal Intervertebral Body
Root cause (FDA): Under Investigation by firm
What the company told customers: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Recall number: Z-1799-2021

Atec Insignia Anterior Cervical Plate System…

Product: Atec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-Level, 17 mm, Rx Only, Non-Sterile, UDI: (01)00190376268439
Quantity: 6 units
Codes and lots: 8663405R and 8800402
Recall started: April 26, 2021
Device type: Appliance, Fixation, Spinal Intervertebral Body
Root cause (FDA): Under Investigation by firm
What the company told customers: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Recall number: Z-1800-2021

Atec Insignia Anterior Cervical Plate System…

Product: Atec Insignia Anterior Cervical Plate System, REF 136-0118, Insignia, ACP, 1-Level, 18 mm, Rx Only, Non-Sterile, UDI: (01)00190376268446
Quantity: 7 units
Codes and lots: 8609303R and 8800403
Recall started: April 26, 2021
Device type: Appliance, Fixation, Spinal Intervertebral Body
Root cause (FDA): Under Investigation by firm
What the company told customers: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Recall number: Z-1801-2021

Atec Insignia Anterior Cervical Plate System…

Product: Atec Insignia Anterior Cervical Plate System, REF 136-0119, Insignia, ACP, 1-Level, 19 mm, Rx Only, Non-Sterile, UDI: (01)00190376268453
Quantity: 13 units
Codes and lots: 8609304R
Recall started: April 26, 2021
Device type: Appliance, Fixation, Spinal Intervertebral Body
Root cause (FDA): Under Investigation by firm
What the company told customers: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Recall number: Z-1802-2021

Atec Insignia Anterior Cervical Plate System…

Product: Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, Non-Sterile, UDI: (01)00190376268460
Quantity: 10 units
Codes and lots: 8609305R
Recall started: April 26, 2021
Device type: Appliance, Fixation, Spinal Intervertebral Body
Root cause (FDA): Under Investigation by firm
What the company told customers: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Recall number: Z-1803-2021

Atec Insignia Anterior Cervical Plate System…

Product: Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21 mm, Rx Only, Non-Sterile, UDI: (01)00190376268477
Quantity: 7 units
Codes and lots: 8609306R
Recall started: April 26, 2021
Device type: Appliance, Fixation, Spinal Intervertebral Body
Root cause (FDA): Under Investigation by firm
What the company told customers: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Recall number: Z-1804-2021

Atec Insignia Anterior Cervical Plate System…

Product: Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-Level, 22 mm, Rx Only, Non-Sterile, UDI: (01)00190376268484
Quantity: 8 units
Codes and lots: 8609307R
Recall started: April 26, 2021
Device type: Appliance, Fixation, Spinal Intervertebral Body
Root cause (FDA): Under Investigation by firm
What the company told customers: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Recall number: Z-1805-2021

Atec Insignia Anterior Cervical Plate System…

Product: Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24 mm, Rx Only, Non-Sterile, UDI: (01)00190376268743
Quantity: 8 units
Codes and lots: 8609309R
Recall started: April 26, 2021
Device type: Appliance, Fixation, Spinal Intervertebral Body
Root cause (FDA): Under Investigation by firm
What the company told customers: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Recall number: Z-1806-2021

Atec Insignia Anterior Cervical Plate System…

Product: Atec Insignia Anterior Cervical Plate System, REF 136-0232 Insignia, ACP, 2-Level, 32 mm, Rx Only, Non-Sterile, UDI: (01)00190376268361
Quantity: 3 units
Codes and lots: 8609312R
Recall started: April 26, 2021
Device type: Appliance, Fixation, Spinal Intervertebral Body
Root cause (FDA): Under Investigation by firm
What the company told customers: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Recall number: Z-1807-2021

Atec Insignia Anterior Cervical Plate System…

Product: Atec Insignia Anterior Cervical Plate System, REF 136-0234 Insignia, ACP, 2-Level, 34 mm, Rx Only, Non-Sterile, UDI: (01)00190376268378
Quantity: 6 units
Codes and lots: 8609313R and 8800410
Recall started: April 26, 2021
Device type: Appliance, Fixation, Spinal Intervertebral Body
Root cause (FDA): Under Investigation by firm
What the company told customers: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Recall number: Z-1808-2021

Atec Insignia Anterior Cervical Plate System…

Product: Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-Level, 36 mm, Rx Only, Non-Sterile, UDI: (01)00190376268385
Quantity: 18 units
Codes and lots: 8609314R
Recall started: April 26, 2021
Device type: Appliance, Fixation, Spinal Intervertebral Body
Root cause (FDA): Under Investigation by firm
What the company told customers: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Recall number: Z-1809-2021

Atec Insignia Anterior Cervical Plate System…

Product: Atec Insignia Anterior Cervical Plate System, REF 136-0238 Insignia, ACP, 2-Level, 38 mm, Rx Only, Non-Sterile, UDI: (01)00190376268392
Quantity: 19 units
Codes and lots: 8609315R
Recall started: April 26, 2021
Device type: Appliance, Fixation, Spinal Intervertebral Body
Root cause (FDA): Under Investigation by firm
What the company told customers: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Recall number: Z-1810-2021

Atec Insignia Anterior Cervical Plate System…

Product: Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01)00190376268408
Quantity: 26 units
Codes and lots: 8663401R, 8609316R
Recall started: April 26, 2021
Device type: Appliance, Fixation, Spinal Intervertebral Body
Root cause (FDA): Under Investigation by firm
What the company told customers: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Recall number: Z-1811-2021

Atec Insignia Anterior Cervical Plate System…

Product: Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42 mm, Rx Only, Non-Sterile, UDI: (01)00190376268415
Quantity: 14 units
Codes and lots: 8663402R and 8609317R
Recall started: April 26, 2021
Device type: Appliance, Fixation, Spinal Intervertebral Body
Root cause (FDA): Under Investigation by firm
What the company told customers: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Recall number: Z-1812-2021

Atec Insignia Anterior Cervical Plate System…

Product: Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44 mm, Rx Only, Non-Sterile, UDI: (01)00190376268507
Quantity: 3 units
Codes and lots: 8663403R & 8609318R
Recall started: April 26, 2021
Device type: Appliance, Fixation, Spinal Intervertebral Body
Root cause (FDA): Under Investigation by firm
What the company told customers: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Recall number: Z-1813-2021

Atec Insignia Anterior Cervical Plate System…

Product: Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48 mm, Rx Only, Non-Sterile, UDI: (01)00190376268521
Quantity: 3 units
Codes and lots: 8609319R and 8663404R
Recall started: April 26, 2021
Device type: Appliance, Fixation, Spinal Intervertebral Body
Root cause (FDA): Under Investigation by firm
What the company told customers: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Recall number: Z-1814-2021

Atec Insignia Anterior Cervical Plate System…

Product: Atec Insignia Anterior Cervical Plate System, REF 136-0250 Insignia, ACP, 2-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268538
Quantity: 1 unit
Codes and lots: 8663405R
Recall started: April 26, 2021
Device type: Appliance, Fixation, Spinal Intervertebral Body
Root cause (FDA): Under Investigation by firm
What the company told customers: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Recall number: Z-1815-2021

Atec Insignia Anterior Cervical Plate System…

Product: Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268569
Quantity: N/A
Codes and lots: 8609322R
Recall started: April 26, 2021
Device type: Appliance, Fixation, Spinal Intervertebral Body
Root cause (FDA): Under Investigation by firm
What the company told customers: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Recall number: Z-1816-2021

Atec Insignia Anterior Cervical Plate System…

Product: Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52 mm, Rx Only, Non-Sterile, UDI: (01)00190376268576
Quantity: 4 units
Codes and lots: 8609323R
Recall started: April 26, 2021
Device type: Appliance, Fixation, Spinal Intervertebral Body
Root cause (FDA): Under Investigation by firm
What the company told customers: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Recall number: Z-1817-2021

Atec Insignia Anterior Cervical Plate System…

Product: Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, Non-Sterile, UDI: (01)00190376268583
Quantity: 7 units
Codes and lots: 8609324R
Recall started: April 26, 2021
Device type: Appliance, Fixation, Spinal Intervertebral Body
Root cause (FDA): Under Investigation by firm
What the company told customers: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Recall number: Z-1818-2021

Atec Insignia Anterior Cervical Plate System…

Product: Atec Insignia Anterior Cervical Plate System, REF 136-0356 Insignia, ACP, 3-Level, 56 mm, Rx Only, Non-Sterile, UDI: (01)00190376268590
Quantity: 5 units
Codes and lots: 8609325R
Recall started: April 26, 2021
Device type: Appliance, Fixation, Spinal Intervertebral Body
Root cause (FDA): Under Investigation by firm
What the company told customers: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Recall number: Z-1819-2021

Atec Insignia Anterior Cervical Plate System…

Product: Atec Insignia Anterior Cervical Plate System, REF 136-0358 Insignia, ACP, 3-Level, 58 mm, Rx Only, Non-Sterile, UDI: (01)00190376268606
Quantity: 3 units
Codes and lots: 8609326R
Recall started: April 26, 2021
Device type: Appliance, Fixation, Spinal Intervertebral Body
Root cause (FDA): Under Investigation by firm
What the company told customers: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Recall number: Z-1820-2021

Atec Insignia Anterior Cervical Plate System…

Product: Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-Level, 60 mm, Rx Only, Non-Sterile, UDI: (01)00190376268613
Quantity: 1 units
Codes and lots: 8609327R
Recall started: April 26, 2021
Device type: Appliance, Fixation, Spinal Intervertebral Body
Root cause (FDA): Under Investigation by firm
What the company told customers: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Recall number: Z-1821-2021

Atec Insignia Anterior Cervical Plate System…

Product: Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62 mm, Rx Only, Non-Sterile, UDI: (01)00190376268620
Quantity: 7 units
Codes and lots: 8609328R
Recall started: April 26, 2021
Device type: Appliance, Fixation, Spinal Intervertebral Body
Root cause (FDA): Under Investigation by firm
What the company told customers: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Recall number: Z-1822-2021

Atec Insignia Anterior Cervical Plate System…

Product: Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64 mm, Rx Only, Non-Sterile, UDI: (01)00190376268637
Quantity: 1 units
Codes and lots: 8609329R
Recall started: April 26, 2021
Device type: Appliance, Fixation, Spinal Intervertebral Body
Root cause (FDA): Under Investigation by firm
What the company told customers: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Recall number: Z-1823-2021

Atec Insignia Anterior Cervical Plate System…

Product: Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68 mm, Rx Only, Non-Sterile, UDI: (01)00190376268675
Quantity: 2 units
Codes and lots: 8609331R
Recall started: April 26, 2021
Device type: Appliance, Fixation, Spinal Intervertebral Body
Root cause (FDA): Under Investigation by firm
What the company told customers: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Recall number: Z-1824-2021

Atec Insignia Anterior Cervical Plate System…

Product: Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-Level, 74 mm, Rx Only, Non-Sterile, UDI: (01)00190376268699
Quantity: 5 units
Codes and lots: 8609333R
Recall started: April 26, 2021
Device type: Appliance, Fixation, Spinal Intervertebral Body
Root cause (FDA): Under Investigation by firm
What the company told customers: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Recall number: Z-1825-2021

Atec Insignia Anterior Cervical Plate System…

Product: Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-Level, 78 mm, Rx Only, Non-Sterile, UDI: (01)00190376268705
Quantity: 1 unit
Codes and lots: 8609334R
Recall started: April 26, 2021
Device type: Appliance, Fixation, Spinal Intervertebral Body
Root cause (FDA): Under Investigation by firm
What the company told customers: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Recall number: Z-1826-2021

Atec Insignia Anterior Cervical Plate System…

Product: Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82 mm, Rx Only, Non-Sterile, UDI: (01)00190376268712
Quantity: 1 unit
Codes and lots: 8609335R
Recall started: April 26, 2021
Device type: Appliance, Fixation, Spinal Intervertebral Body
Root cause (FDA): Under Investigation by firm
What the company told customers: Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3. Please fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions as described in this notification. 4. Please return page 4 (signed) of this letter using one of the methods below: Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Hylene Valdez Email to: QMScompliance@atecspine.com 5. Please share this notice with all those who need to be aware within your organization or any organization where the affected product has been transferred. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to Alphatec at 1-800-922-1356 or 1-760-431-9286. The FDAs MedWatch Adverse Event reporting program can also be used, via email, on-line or fax.
Recall number: Z-1827-2021

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-1799-2021, Z-1800-2021, Z-1801-2021, Z-1802-2021, Z-1803-2021, Z-1804-2021, Z-1805-2021, Z-1806-2021 and others. The agency record governs; check it and the company before acting.

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