FDA DevicesClass II
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205...
Published: May 6, 2026Recall ID: Z-1991-2026Category: devicesCountry: US
Reason for Recall / Hazard
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Product Description & Identification
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.
Additional Source Details
| Field | Value |
|---|---|
| City | Co. Cork |
| Event id | 98707 |
| Address 1 | Loughbeg, Ringaskiddy |
| Code info | Part Number: 150450205. UDI-DI: 10603295533160. Lot Number: 1006444. Expiration Date: 10/31/2035. |
| Postal code | N/A |
| Report date | 20260506 |
| Product type | Devices |
| Product quantity | 3 units |
| Reason for recall | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260403 |
| Initial firm notification | |
| Center classification date | 20260429 |
Overview
- Recalling FirmDEPUY (IRELAND)
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of MN, NC, TX.