FDAJune 19, 2024device
UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-038
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
07613327032338
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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