Device product
UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-038
Z-2372-2024
Product summary
- Event
- Event 94871
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 12 units
- Official record key
device-enforcement:Z-2372-2024
Official wording
Reason: 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)
Code information: GTIN: 07613327032338 Lot Numbers: JT38AD, E94VEV
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, and UK.
Derived failure modes
-
Labeling or packaging
Mislabeled