Z-2370-2024 Class II Ongoing
FDA device recall Z-2370-2024 was initiated by Howmedica Osteonics Corp. on Jun 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: 18 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 24, 2024
- Initiation Date
- Jun 19, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 units
Product Description
UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-043
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: 07613327032376 Lot Numbers: 5Y1350, LN815R, PV0H60
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2370-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026