ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a… — Class II medical device recall Z-0631-2022
Terminated recall by DePuy Orthopaedics, Inc., reported 2022-02-16, distributed nationwide. May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation
| Recall number | Z-0631-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2022-01-05 |
| Classified | 2022-02-09 |
| Reported by FDA | 2022-02-16 |
| Terminated | 2023-12-22 |
| Distributed | Nationwide (US) |
| Quantity | 6 units |
| UPC / GTIN / UDI-DI | 10603295383178 |
| Lot numbers | JH9649, JH9651 |
Product
ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003
Reason for recall
May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0631-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.