Z-1985-2026 Class II Ongoing
FDA device recall Z-1985-2026 was initiated by DEPUY (IRELAND) on April 3, 2026 and is designated Class II. Reason for recall: The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. The recall status is ongoing. Affected quantity: 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2026
- Initiation Date
- April 3, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.
Reason for Recall
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Distribution Pattern
US Nationwide distribution in the states of MN, NC, TX.
Code Information
Part Number: 150450104. UDI-DI: 10603295533115. Lot Number: 1007844. Expiration Date: 11/30/2035