Recall Z-1989-2026 · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
DEPUY (IRELAND)
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.
| Date | Apr 29, 2026 (initiated Apr 3, 2026) |
| Status | Open, Classified |
| Reason | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 3 units |
| Distribution | US Nationwide distribution in the states of MN, NC, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K242871 | ATTUNE Revision Hinge Knee Depuy Ireland UC, Nov 21, 2024 |