Recall Z-2617-2026 · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
DEPUY (IRELAND)
Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 10mm B; Part Number: 151730410. 2. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 12mm B; Part Number: 151730412. 3. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 14mm B; Part Number: 151730414. 4. ATTUNE KNEE SYSTEM REVISION HINGE INSE
| Date | Jun 29, 2026 (initiated May 19, 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 Synthes notified consignees on about 0519/2026 via email. Consignees were instructed to examine inventory and quarantine any affected units on hand, contact the DePuy Sunthes Sales Consultant or customer support to coordinate the return of affected units, complete and return the Business Response Form, forward the notification to anyone in each facility that needs to be informed, and if any of the affected units have been sold or transferred to contact that facility and provide the notification. Consignees were also requested to post a copy of the notification in a visible area for aware |
| Quantity | 160 units |
| Distribution | Distribution to 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 |