← FDA ENFORCEMENT
Z-1993-2026Class II

DEPUY (IRELAND)

Recalling firm
DEPUY (IRELAND)
Product type
Device
Status
Ongoing
Report date
2026-05-06
Distribution
US Nationwide distribution in the states of MN, NC, TX.
Product quantity
3 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

Product description

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.

Code / lot info

Part Number: 150450208. UDI-DI: 10603295543039. Lot Numbers: AF1008441, AF1008028. Expiration Date: 12/31/2035.

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.