FDA recall Z-2372-2024

Product

UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-038

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)

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, and UK.

Key facts

Status

Ongoing

Initiation date

2024-06-19

Report date

2024-07-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2372-2024