PlainRecordsFDA · Medical device recall
TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision… and 11 more products
- Reason
- The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Status
- Ongoing
- Distribution
- Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
- Enforcement report date
- May 1, 2024
- 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
- Ongoing (FDA has not recorded a termination for this recall; FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- Howmedica Osteonics Corp.
- Reason
- The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Distribution pattern
- Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
What this record is about
A generic icon of the kind of thing the record is about; the record's own words are below. It is not a picture of the product.
“The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell”TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-44B, FDA enforcement report, 2024-05-01. The caption is the record's own words.
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FDA device name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
12 products in this recall
TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation…
- Product
- TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-44B
- Quantity
- 0
- Codes and lots
- UDI-DI: (01)07613327380897(17)290313(10) Lot Number: 14974852
- Recall started
- Feb. 27, 2024
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- Stryker issued Urgent Medical Device Recall (UMDR) PFA 3529813 by Sedgwick on Feb. 27, 2024, via UPS 2-day air. An OUS customer notification will also be issued at the country level. Letter states reason for recall and action to take: Technical and medical assessments are currently underway to determine any potential hazards and harms associated with the use of an impacted Trident II Acetabular Shell. An updated communication will be forwarded upon completion of the internal investigation of this issue. 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware or organizations who have consigned product. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the recalled devices identified in the affected product list. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email to " Medical Facility: Please sign the Business Reply Form and email to: strykerortho4091@sedgwick.com / Fax: (833) 237-1022 " Stryker Branch/Agency: please sign the AdobeSign form arriving to you via email. 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. 6. Please return the devices to Stryker using the following address: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 3529813 If you have any questions or concerns after reviewing this letter, please contact Customer Service at (888)-756-7846. For questions pertaining to the recall, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com
- Recall number
- Z-1621-2024
TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation…
- Product
- TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-48D
- Quantity
- 45 units
- Codes and lots
- UDI-DI: (01)07613327380903(17)290313(10) Lot Number: 14875651 15005253 16044255
- Recall started
- Feb. 27, 2024
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- Stryker issued Urgent Medical Device Recall (UMDR) PFA 3529813 by Sedgwick on Feb. 27, 2024, via UPS 2-day air. An OUS customer notification will also be issued at the country level. Letter states reason for recall and action to take: Technical and medical assessments are currently underway to determine any potential hazards and harms associated with the use of an impacted Trident II Acetabular Shell. An updated communication will be forwarded upon completion of the internal investigation of this issue. 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware or organizations who have consigned product. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the recalled devices identified in the affected product list. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email to " Medical Facility: Please sign the Business Reply Form and email to: strykerortho4091@sedgwick.com / Fax: (833) 237-1022 " Stryker Branch/Agency: please sign the AdobeSign form arriving to you via email. 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. 6. Please return the devices to Stryker using the following address: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 3529813 If you have any questions or concerns after reviewing this letter, please contact Customer Service at (888)-756-7846. For questions pertaining to the recall, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com
- Recall number
- Z-1622-2024
TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation…
- Product
- TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-50D
- Quantity
- 0
- Codes and lots
- UDI-DI: (01)07613327381047(17)290313(10) Lot Number: 14629051 14628851 15175654 15610452
- Recall started
- Feb. 27, 2024
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- Stryker issued Urgent Medical Device Recall (UMDR) PFA 3529813 by Sedgwick on Feb. 27, 2024, via UPS 2-day air. An OUS customer notification will also be issued at the country level. Letter states reason for recall and action to take: Technical and medical assessments are currently underway to determine any potential hazards and harms associated with the use of an impacted Trident II Acetabular Shell. An updated communication will be forwarded upon completion of the internal investigation of this issue. 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware or organizations who have consigned product. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the recalled devices identified in the affected product list. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email to " Medical Facility: Please sign the Business Reply Form and email to: strykerortho4091@sedgwick.com / Fax: (833) 237-1022 " Stryker Branch/Agency: please sign the AdobeSign form arriving to you via email. 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. 6. Please return the devices to Stryker using the following address: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 3529813 If you have any questions or concerns after reviewing this letter, please contact Customer Service at (888)-756-7846. For questions pertaining to the recall, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com
- Recall number
- Z-1623-2024
TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation…
- Product
- TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-52E
- Quantity
- 48 units
- Codes and lots
- UDI-DI: (01)07613327380859(17)290313(10 Lot Number: 14875853 14875852
- Recall started
- Feb. 27, 2024
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- Stryker issued Urgent Medical Device Recall (UMDR) PFA 3529813 by Sedgwick on Feb. 27, 2024, via UPS 2-day air. An OUS customer notification will also be issued at the country level. Letter states reason for recall and action to take: Technical and medical assessments are currently underway to determine any potential hazards and harms associated with the use of an impacted Trident II Acetabular Shell. An updated communication will be forwarded upon completion of the internal investigation of this issue. 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware or organizations who have consigned product. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the recalled devices identified in the affected product list. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email to " Medical Facility: Please sign the Business Reply Form and email to: strykerortho4091@sedgwick.com / Fax: (833) 237-1022 " Stryker Branch/Agency: please sign the AdobeSign form arriving to you via email. 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. 6. Please return the devices to Stryker using the following address: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 3529813 If you have any questions or concerns after reviewing this letter, please contact Customer Service at (888)-756-7846. For questions pertaining to the recall, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com
- Recall number
- Z-1624-2024
TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation…
- Product
- TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-54E
- Quantity
- 225 units
- Codes and lots
- UDI-DI:(01)07613327380880(17)290313(10) Lot Number: 15293151 15293153 15293152 15432252 15432254 15432451 15432351 15432251 15432253 16265752
- Recall started
- Feb. 27, 2024
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- Stryker issued Urgent Medical Device Recall (UMDR) PFA 3529813 by Sedgwick on Feb. 27, 2024, via UPS 2-day air. An OUS customer notification will also be issued at the country level. Letter states reason for recall and action to take: Technical and medical assessments are currently underway to determine any potential hazards and harms associated with the use of an impacted Trident II Acetabular Shell. An updated communication will be forwarded upon completion of the internal investigation of this issue. 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware or organizations who have consigned product. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the recalled devices identified in the affected product list. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email to " Medical Facility: Please sign the Business Reply Form and email to: strykerortho4091@sedgwick.com / Fax: (833) 237-1022 " Stryker Branch/Agency: please sign the AdobeSign form arriving to you via email. 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. 6. Please return the devices to Stryker using the following address: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 3529813 If you have any questions or concerns after reviewing this letter, please contact Customer Service at (888)-756-7846. For questions pertaining to the recall, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com
- Recall number
- Z-1625-2024
TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation…
- Product
- TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-58F
- Quantity
- 0
- Codes and lots
- UDI-DI: (01)07613327380958(17)290313(10) Lot Number: 15854353
- Recall started
- Feb. 27, 2024
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- Stryker issued Urgent Medical Device Recall (UMDR) PFA 3529813 by Sedgwick on Feb. 27, 2024, via UPS 2-day air. An OUS customer notification will also be issued at the country level. Letter states reason for recall and action to take: Technical and medical assessments are currently underway to determine any potential hazards and harms associated with the use of an impacted Trident II Acetabular Shell. An updated communication will be forwarded upon completion of the internal investigation of this issue. 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware or organizations who have consigned product. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the recalled devices identified in the affected product list. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email to " Medical Facility: Please sign the Business Reply Form and email to: strykerortho4091@sedgwick.com / Fax: (833) 237-1022 " Stryker Branch/Agency: please sign the AdobeSign form arriving to you via email. 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. 6. Please return the devices to Stryker using the following address: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 3529813 If you have any questions or concerns after reviewing this letter, please contact Customer Service at (888)-756-7846. For questions pertaining to the recall, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com
- Recall number
- Z-1626-2024
TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation…
- Product
- TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-66H
- Quantity
- 0
- Codes and lots
- UDI-DI: (01)07613327380835(17)290313(10) Lot Number: 15445252
- Recall started
- Feb. 27, 2024
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Kit, Assay, Estrogen Receptor
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- Stryker issued Urgent Medical Device Recall (UMDR) PFA 3529813 by Sedgwick on Feb. 27, 2024, via UPS 2-day air. An OUS customer notification will also be issued at the country level. Letter states reason for recall and action to take: Technical and medical assessments are currently underway to determine any potential hazards and harms associated with the use of an impacted Trident II Acetabular Shell. An updated communication will be forwarded upon completion of the internal investigation of this issue. 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware or organizations who have consigned product. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the recalled devices identified in the affected product list. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email to " Medical Facility: Please sign the Business Reply Form and email to: strykerortho4091@sedgwick.com / Fax: (833) 237-1022 " Stryker Branch/Agency: please sign the AdobeSign form arriving to you via email. 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. 6. Please return the devices to Stryker using the following address: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 3529813 If you have any questions or concerns after reviewing this letter, please contact Customer Service at (888)-756-7846. For questions pertaining to the recall, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com
- Recall number
- Z-1627-2024
TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation…
- Product
- TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-48D
- Quantity
- 0
- Codes and lots
- UDI-DI: (01)07613327380941(17)290313(10) Lot Number: 16311453
- Recall started
- Feb. 27, 2024
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- Stryker issued Urgent Medical Device Recall (UMDR) PFA 3529813 by Sedgwick on Feb. 27, 2024, via UPS 2-day air. An OUS customer notification will also be issued at the country level. Letter states reason for recall and action to take: Technical and medical assessments are currently underway to determine any potential hazards and harms associated with the use of an impacted Trident II Acetabular Shell. An updated communication will be forwarded upon completion of the internal investigation of this issue. 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware or organizations who have consigned product. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the recalled devices identified in the affected product list. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email to " Medical Facility: Please sign the Business Reply Form and email to: strykerortho4091@sedgwick.com / Fax: (833) 237-1022 " Stryker Branch/Agency: please sign the AdobeSign form arriving to you via email. 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. 6. Please return the devices to Stryker using the following address: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 3529813 If you have any questions or concerns after reviewing this letter, please contact Customer Service at (888)-756-7846. For questions pertaining to the recall, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com
- Recall number
- Z-1628-2024
TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation…
- Product
- TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-50D
- Quantity
- 0
- Codes and lots
- UDI-DI:(01)07613327381009(17)290313(10) Lot Number: 14593551 15432653 15432651
- Recall started
- Feb. 27, 2024
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- Stryker issued Urgent Medical Device Recall (UMDR) PFA 3529813 by Sedgwick on Feb. 27, 2024, via UPS 2-day air. An OUS customer notification will also be issued at the country level. Letter states reason for recall and action to take: Technical and medical assessments are currently underway to determine any potential hazards and harms associated with the use of an impacted Trident II Acetabular Shell. An updated communication will be forwarded upon completion of the internal investigation of this issue. 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware or organizations who have consigned product. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the recalled devices identified in the affected product list. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email to " Medical Facility: Please sign the Business Reply Form and email to: strykerortho4091@sedgwick.com / Fax: (833) 237-1022 " Stryker Branch/Agency: please sign the AdobeSign form arriving to you via email. 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. 6. Please return the devices to Stryker using the following address: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 3529813 If you have any questions or concerns after reviewing this letter, please contact Customer Service at (888)-756-7846. For questions pertaining to the recall, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com
- Recall number
- Z-1629-2024
TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation…
- Product
- TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-52E
- Quantity
- 3 units
- Codes and lots
- UDI-DI: (01)07613327381023(17)290313(10) Lot Number: 14876553 14876552
- Recall started
- Feb. 27, 2024
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- Stryker issued Urgent Medical Device Recall (UMDR) PFA 3529813 by Sedgwick on Feb. 27, 2024, via UPS 2-day air. An OUS customer notification will also be issued at the country level. Letter states reason for recall and action to take: Technical and medical assessments are currently underway to determine any potential hazards and harms associated with the use of an impacted Trident II Acetabular Shell. An updated communication will be forwarded upon completion of the internal investigation of this issue. 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware or organizations who have consigned product. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the recalled devices identified in the affected product list. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email to " Medical Facility: Please sign the Business Reply Form and email to: strykerortho4091@sedgwick.com / Fax: (833) 237-1022 " Stryker Branch/Agency: please sign the AdobeSign form arriving to you via email. 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. 6. Please return the devices to Stryker using the following address: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 3529813 If you have any questions or concerns after reviewing this letter, please contact Customer Service at (888)-756-7846. For questions pertaining to the recall, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com
- Recall number
- Z-1630-2024
TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation…
- Product
- TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-58F
- Quantity
- 0
- Codes and lots
- UDI-DI: (01)07613327380811(17)290313(10) Lot Number: 13927651
- Recall started
- Feb. 27, 2024
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- Stryker issued Urgent Medical Device Recall (UMDR) PFA 3529813 by Sedgwick on Feb. 27, 2024, via UPS 2-day air. An OUS customer notification will also be issued at the country level. Letter states reason for recall and action to take: Technical and medical assessments are currently underway to determine any potential hazards and harms associated with the use of an impacted Trident II Acetabular Shell. An updated communication will be forwarded upon completion of the internal investigation of this issue. 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware or organizations who have consigned product. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the recalled devices identified in the affected product list. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email to " Medical Facility: Please sign the Business Reply Form and email to: strykerortho4091@sedgwick.com / Fax: (833) 237-1022 " Stryker Branch/Agency: please sign the AdobeSign form arriving to you via email. 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. 6. Please return the devices to Stryker using the following address: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 3529813 If you have any questions or concerns after reviewing this letter, please contact Customer Service at (888)-756-7846. For questions pertaining to the recall, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com
- Recall number
- Z-1631-2024
TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation…
- Product
- TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-64H
- Quantity
- 0
- Codes and lots
- UDI-DI: (01)07613327380927(17)290313(10) Lot Number: 15611151
- Recall started
- Feb. 27, 2024
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- Stryker issued Urgent Medical Device Recall (UMDR) PFA 3529813 by Sedgwick on Feb. 27, 2024, via UPS 2-day air. An OUS customer notification will also be issued at the country level. Letter states reason for recall and action to take: Technical and medical assessments are currently underway to determine any potential hazards and harms associated with the use of an impacted Trident II Acetabular Shell. An updated communication will be forwarded upon completion of the internal investigation of this issue. 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware or organizations who have consigned product. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the recalled devices identified in the affected product list. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email to " Medical Facility: Please sign the Business Reply Form and email to: strykerortho4091@sedgwick.com / Fax: (833) 237-1022 " Stryker Branch/Agency: please sign the AdobeSign form arriving to you via email. 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. 6. Please return the devices to Stryker using the following address: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 3529813 If you have any questions or concerns after reviewing this letter, please contact Customer Service at (888)-756-7846. For questions pertaining to the recall, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com
- Recall number
- Z-1632-2024
This recall among the others
- FDA's enforcement report came 64 days after the firm started the recall. For half of the 1,034 FDA medical device recall events reported in 2024 with a start date, it took 51 days or fewer (by year).
- Howmedica Osteonics: 16 other recalls or notices on this site in the three years before this one (from May 2, 2021).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement reports, recall numbers Z-1621-2024, Z-1622-2024, Z-1623-2024, Z-1624-2024, Z-1625-2024, Z-1626-2024, Z-1627-2024, Z-1628-2024 and others. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-1621-2024, May 1, 2024. "TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision… and 11 more products." PlainRecords, https://plainrecords.com/recall/device/z-1621-2024/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections