FDAFDA · Food and drugs·Recall number Z-2370-2024
UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-043
Published July 24, 2024 · Recall initiated: June 19, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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)
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Howmedica Osteonics Corp.
- Distributor
- Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, and UK.
- Lot
- GTIN: 07613327032376 Lot Numbers: 5Y1350, LN815R, PV0H60
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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