Recall Z-0651-2022— Howmedica Osteonics Corp.

Name: FDA recall Z-0651-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-30

Class II · Terminated

Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2021-12-30, terminated 2024-03-14. It names one FDA 510(k) clearance: K121308. Product: Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044. Reason: There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem..

Recalling firm: Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2021-12-30
Terminated: 2024-03-14
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K121308 — HIP SYSTEMSHowmedica Osteonics Corp.·cleared 2012-07-30

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

Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044

Reason for recall

There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.

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