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

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)

Details from the source

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. Quantity: 18 units Lot/code info: GTIN: 07613327032369 Lot Numbers: 4615EX, HE645D, 8A399N

UPC codes

07613327032369

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.