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FDAJanuary 5, 2022device

ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154706001

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.

What to do

FDA enforcement status: Terminated

Brands named

depuy orthopaedicsdepuy

UPCs

10603295382775

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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