FDA Medical Device Recalls (openFDA)
DePuy Orthopaedics, Inc.: ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
- Recall number
- Z-2348-2021
- Recalling firm
- DePuy Orthopaedics, Inc.
- Product
- ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
- Status
- Terminated
- Initiated
- 2021-07-01
- Posted
- not on file
- Terminated
- 2023-02-01
- Reason
- Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement
- Root cause
- Process change control
- Action
- 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.
- Quantity
- 7 units
- Distribution
- International distribution in the countries of Canada, France.
- Lot, serial or model codes
- Lot Number: J82N61 Expiry Date: 31May2030 GTIN: 10603295043010
- 510(k) numbers
- ["K160700"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 1818910
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28