Howmedica Osteonics Corp.: UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-043

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: 07613327032376 Lot Numbers: 5Y1350, LN815R, PV0H60

UPC codes

07613327032376

Source

Official record: FDA (Device enforcement) ↗

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