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FDAApril 13, 2023device

TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E

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

The hazard

Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa

What to do

FDA enforcement status: Ongoing

Brands named

howmedica osteonicshowmedica

UPCs

07613327390698

Recall history

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

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