Howmedica Osteonics Corp.: Medical Device Recall in 2024 - (Recall #: Z-2371-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-042

Product Classification:

Class II

Date Initiated: June 19, 2024

Date Posted: July 24, 2024

Recall Number: Z-2371-2024

Event ID: 94871

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)

Status: Ongoing

Product Quantity: 18 units

Code Information:

GTIN: 07613327032369 Lot Numbers: 4615EX, HE645D, 8A399N

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated