UNITRAX Endoprosthesis Head Component — Class II medical device recall Z-2371-2024
Ongoing recall by Howmedica Osteonics Corp., reported 2024-07-24, distributed nationwide. Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not ma
| Recall number | Z-2371-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2024-06-19 |
| Classified | 2024-07-16 |
| Reported by FDA | 2024-07-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, GB, HK |
| Quantity | 18 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 07613327032369 |
| Lot numbers | 4615EX, 8A399N, HE645D |
| Model numbers | 6942-5-042 |
Product
UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-042
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)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2371-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.