Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below product descriptions and Part Codes. 1.
FDA device recall Z-2617-2026 · posted 2026-06-29 · 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 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 awareness and keep a copy for your records.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- KRO
- Quantity affected
- 160 units
- Distribution
- Distribution to MN, NC, TX.
- Date initiated
- 2026-05-19
- Date posted
- 2026-06-29
- Location
- Ringaskiddy Co. Cork, Ireland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ATTUNE™ Revision Hinge Knee (K242871) | Depuy Ireland UC | 2024-11-21 |