Depuy Synthes — Class II medical device recall Z-1993-2026
Ongoing recall by DEPUY (IRELAND), reported 2026-05-06, distributed nationwide. The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising s
| Recall number | Z-1993-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DEPUY (IRELAND), Co. Cork, Ireland |
| Recall initiated | 2026-04-03 |
| Classified | 2026-04-29 |
| Reported by FDA | 2026-05-06 |
| Distributed | Nationwide (US) |
| Quantity | 3 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10603295543039 |
| Lot numbers | AF1008028, AF1008441 |
| Model numbers | 150450208 |
| Expiration dates | 2035-12-31 |
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.
Reason for recall
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
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-1993-2026. 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.