FDA Device recall Z-2371-2024
UNITRAX Endoprosthesis Head Component - 42mm
- FDA Device
- Class II
- ongoing
- Published 2024-07-24
On 2024-07-24 the FDA classified a Class II recall of UNITRAX Endoprosthesis Head Component - 42mm by Howmedica Osteonics, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2371-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-19 |
| Published | 2024-07-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Howmedica Osteonics |
| Distribution | US |
Product
UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-042
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)
Identifiers
| code_info | GTIN: 07613327032369 Lot Numbers: 4615EX, HE645D, 8A399N |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2371-2024%22
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