Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207.
FDA device recall Z-1992-2026 · posted 2026-04-29 · Open, Classified
Recall details
- Recalling firm
- DEPUY (IRELAND)
- Reason for recall
- The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- Action taken
- Depuy Ireland notified consignees on about 04/03/2026 via email. Consignees were instructed to examine inventory for affected units and immediately quarantine them, arrange for the return of all affected units, and complete and return the provided Business Response Form. Consignees were also instructed to forward the notification letter to anyone within each facility that needs to be informed, notify customers if affected units were further distributed and post a copy of the notification letter in a visible area for awareness.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- KRO
- Quantity affected
- 3 units
- Distribution
- US Nationwide distribution in the states of MN, NC, TX.
- Date initiated
- 2026-04-03
- Date posted
- 2026-04-29
- Location
- Ringaskiddy Co. Cork, Ireland
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ATTUNE™ Revision Hinge Knee (K242871) | Depuy Ireland UC | 2024-11-21 |