Recall Z-0644-2022— Howmedica Osteonics Corp.

Name: FDA recall Z-0644-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-21

Class II · Ongoing

Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2021-12-21. It names one FDA 510(k) clearance: K121308. Product: 32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032. Reason: There is a potential for the outer Tyvek lid to de-bond from the sealed package..

Recalling firm: Howmedica Osteonics Corp.
Classification: Class II
Status: Ongoing
Initiated: 2021-12-21
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

32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032

Reason for recall

There is a potential for the outer Tyvek lid to de-bond from the sealed package.

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