FDA-Device2024-07-24Class II
UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-042
Howmedica Osteonics Corp.
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)
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, and UK.
Affected count
18 units
Manufactured in
325 Corporate Dr, Mahwah, NJ, United States
Products
UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-042
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2371-2024Don't want to check this manually?
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