DEPUY (IRELAND): Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- DEPUY (IRELAND)
- Product
- Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.
- Reason / hazard
- The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of MN, NC, TX.
- Recall initiated
- 2026-04-03
- Code info
- Part Number: 150450108. UDI-DI: 10603295543022. Lot Number: AF1006441. Expiration Date: 12/31/2035.
- Product quantity
- 3 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Co. Cork
- Country
- Ireland
- Event id
- 98707
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