UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-043
Reported: July 24, 2024 Initiated: June 19, 2024 #Z-2370-2024
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)
Details
- Recalling Firm
- Howmedica Osteonics Corp.
- Units Affected
- 18 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, and UK.
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-043. Recalled by Howmedica Osteonics Corp.. Units affected: 18 units.
Why was this product recalled? ▼
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)
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 24, 2024. Severity: Moderate. Recall number: Z-2370-2024.
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