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FDAJune 19, 2024device

UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-042

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

The hazard

Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)

What to do

FDA enforcement status: Ongoing

Brands named

howmedica osteonicshowmedica

UPCs

07613327032369

Recall history

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

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