Z-2372-2024 Class II Ongoing
FDA device recall Z-2372-2024 was initiated by Howmedica Osteonics Corp. on June 19, 2024 and is designated Class II. 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 (… The recall status is ongoing. Affected quantity: 12 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 24, 2024
- Initiation Date
- June 19, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 units
Product Description
UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-038
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 Pattern
Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, and UK.
Code Information
GTIN: 07613327032338 Lot Numbers: JT38AD, E94VEV