Device product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.
Z-1986-2026
Product summary
- Firm
- DEPUY (IRELAND)
- Event
- Event 98707
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-1986-2026
Official wording
Reason: The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Code information: Part Number: 150450105. UDI-DI: 10603295533122. Lot Number: AF1007829. Expiration Date: 12/31/2035.
Distribution pattern: US Nationwide distribution in the states of MN, NC, TX.
Derived failure modes
-
Unknown
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.