Recall Z-2640-2025— Howmedica Osteonics Corp.

Name: FDA recall Z-2640-2025
Creator: U.S. Food and Drug Administration
Published: 2025-08-28

Class II · Ongoing

Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2025-08-28. It names one FDA 510(k) clearance: K193429. Product: 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;. Reason: a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted..

Recalling firm: Howmedica Osteonics Corp.
Classification: Class II
Status: Ongoing
Initiated: 2025-08-28
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K193429 — Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.·cleared 2020-08-13

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

1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;

Reason for recall

a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.

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