Recall Z-2370-2024— Howmedica Osteonics Corp.

Name: FDA recall Z-2370-2024
Creator: U.S. Food and Drug Administration
Published: 2024-06-19

Class II · Ongoing

Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2024-06-19. It names one FDA 510(k) clearance: K014226. Product: UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-043. 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).

Recalling firm: Howmedica Osteonics Corp.
Classification: Class II
Status: Ongoing
Initiated: 2024-06-19
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K014226 — UNITRAX MODULAR UNIPOLAR SYSTEMHowmedica Osteonics Corp.·cleared 2002-01-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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)

Data sourced from openFDA. This site is unofficial and independent of the FDA.