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FDAJuly 1, 2021device

ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080

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

The hazard

Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement

What to do

FDA enforcement status: Terminated

Brands named

depuy orthopaedicsdepuy

UPCs

10603295043010

Recall history

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

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