ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
This recall has been terminated (originally issued July 1, 2021).
- Company
- Depuy Orthopaedics, Inc.
- Recall Initiated
- July 1, 2021
- Terminated
- February 1, 2023
- Recall Number
- Z-2348-2021
- Quantity
- 7 units
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement
Distribution
International distribution in the countries of Canada, France.
Lot / Code Info
Lot Number: J82N61 Expiry Date: 31May2030 GTIN: 10603295043010
Root Cause
Process change control
Action Taken
DePuy Syntheses issued Medical Device Product Recall (Removal) Ref. 1986537 dated 7/1/21. Letter states reason for recall, health risk and action to take: Please take the Following Steps: 1.Examine your inventory immediately to determine if you have the subject lot and quarantine theproduct. 2.Contact your DePuy Synthes Sales Consultant to coordinate the return of any affected devices or callcustomer service following the typical returns process in order to acquire a return number prior toshipping product. 3.Review, complete, sign, and return the attached business response form (page 3 of this letter) to your localDePuy Synthes sales organization in accordance with the directions on the form within 5 business days ofreceipt of this notification. 4.Forward this notice to anyone in your facility that needs to be informed (i.e., those who manage, transport,store, stock, or use the devices subject to this action). 5.If any of the subject lot has been forwarded to another facility, contact that facility and provide them with thisnotice. 6.Post a copy of this notice in a visible area for awareness and keep a copy for your records. Should you have any other inquiries please do not hesitate to contact your DePuy Synthes Sales Consultant.