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Recall Observatory FDA recall evidence

Device product

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.

Z-1990-2026

April 03, 2026

Class II

Product summary

Firm
DEPUY (IRELAND)
Event
Event 98707
Status
Ongoing
Classification
Class II
Quantity
3 units
Official record key
device-enforcement:Z-1990-2026

Official wording

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

Code information: Part Number: 150450204. UDI-DI: 10603295533153. Lot Number: 1005229. Expiration Date: 10/31/2035.

Distribution pattern: US Nationwide distribution in the states of MN, NC, TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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