FDA · Medical device recall

PROXIMATE¿ HCS Hemorrhoidal Circular Stapler Product Code: PPH01… and 1 more product

Jan. 16, 2019 Class II

Date: Jan. 16, 2019
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: Ethicon Endo-Surgery Inc
Reason: Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially cause bleeding or soft tissue injury during use as the device may not fully cut when fired
Distribution pattern: Worldwide Distribution: US (Nationwide) and to countries of: ARGENTINA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, ECUADOR, EGYPT, INDIA, INDONESIA, JAPAN, KOREA, KUWAIT, LEBANON MEXICO, NICARAGUA, PAKISTAN, SAUDI ARABIA, SINGAPORE, TAIWAN URUGUAY and VIETNAM.

2 products in this recall

PROXIMATE¿ HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: The PROXIMATE¿ HCS Hemorrhoidal…

Product: PROXIMATE¿ HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: The PROXIMATE¿ HCS Hemorrhoidal Circular Stapler and Accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.
Quantity: 480 units
Codes and lots: Lot Codes: P9461W, P94K20
Recall started: Dec. 7, 2018
Device type: Staple, Implantable
Root cause (FDA): Process control
What the company told customers: The firm, Ethicon, issued an "URGENT: MEDICAL DEVICE RECALL (REMOVAL)" to US consignees on 12/7/18, via UPS 2nd day mail. Ethicon Johnson & Johnson Affiliates in North America (Canada), Europe, LATAM, and Asia Pacific will notify their impacted consignees by providing the customer letter through post, email or sales representative visits. Letter identifies reason for recall, action to be taken: examine inventory and return recalled product for replacement; complete the Business Reply Form (BRF) confirming receipt of this notice and fax or email it to Stericycle at 1-844-524-3888 or Ethicon8181@stericycle.com within three (3) business days. Please return the BRF even if you do not have the product lots subject to this recall.. Communicate the issue to relevant operating room or materials management personnel, or anyone else in the facility who needs to be informed. If any product subject to this action has been forwarded to another facility, contact that facility to arrange return. Customers are required to return all PROXIMATE PPH Hemorrhoidal Circular Stapler products subject to this recall that are in their inventory immediately. To receive replacement product, customers must return product subject to this recall by April 1, 2019. Any unused Proximate PPH Hemorrhoidal Circular Stapler product lots subject to this recall returned after April 1, 2019 will not be eligible for replacement. Contact your Ethicon sales representative or contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). The Customer Support Center is open Monday through Friday, 7:30 AM to 6:30 PM ET
Recall number: Z-0695-2019

PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE¿ PPH Hemorrhoidal…

Product: PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease
Quantity: 15,264 units
Codes and lots: Lot Codes: P93K95 P9420Y P94A4T P93L1M P9420Z P94D3N P93M3G P9441H P94F3Z P93T35 P9450L P94G04 P93T7F P9463J P94H5F P93W3M P94765 P94J4W P93W3N P9487Z P94J80 P93Y58 P94901 P94K2A P94117 P94A20 R9200Z
Recall started: Dec. 7, 2018
Device type: Staple, Implantable
Root cause (FDA): Process control
What the company told customers: The firm, Ethicon, issued an "URGENT: MEDICAL DEVICE RECALL (REMOVAL)" to US consignees on 12/7/18, via UPS 2nd day mail. Ethicon Johnson & Johnson Affiliates in North America (Canada), Europe, LATAM, and Asia Pacific will notify their impacted consignees by providing the customer letter through post, email or sales representative visits. Letter identifies reason for recall, action to be taken: examine inventory and return recalled product for replacement; complete the Business Reply Form (BRF) confirming receipt of this notice and fax or email it to Stericycle at 1-844-524-3888 or Ethicon8181@stericycle.com within three (3) business days. Please return the BRF even if you do not have the product lots subject to this recall.. Communicate the issue to relevant operating room or materials management personnel, or anyone else in the facility who needs to be informed. If any product subject to this action has been forwarded to another facility, contact that facility to arrange return. Customers are required to return all PROXIMATE PPH Hemorrhoidal Circular Stapler products subject to this recall that are in their inventory immediately. To receive replacement product, customers must return product subject to this recall by April 1, 2019. Any unused Proximate PPH Hemorrhoidal Circular Stapler product lots subject to this recall returned after April 1, 2019 will not be eligible for replacement. Contact your Ethicon sales representative or contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). The Customer Support Center is open Monday through Friday, 7:30 AM to 6:30 PM ET
Recall number: Z-0696-2019

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

Source: FDA · Medical device enforcement reports, recall numbers Z-0695-2019, Z-0696-2019. The agency record governs; check it and the company before acting.

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