Class II

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

Howmedica Osteonics Corp. · June 19, 2024

Reason for Recall

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)

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, and UK.

States Affected

NATIONWIDE

Quantity Affected

18 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2371-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Howmedica Osteonics Corp. Medical Device Recall: UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-042 | SafeCheck