Recall archive / FDA device enforcement
UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalog Number:... — FDA record Z-2372-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 19, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-038
- 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)
- Classification
- Class II
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 12 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2372-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTIN: 07613327032338 Lot Numbers: JT38AD, E94VEV |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, and UK.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jul 24, 2024
- Recall initiation date
- Jun 19, 2024
- Center classification date
- Jul 16, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.