Recall Z-0081-2021— Biomet, Inc.

Name: FDA recall Z-0081-2021
Creator: U.S. Food and Drug Administration
Published: 2020-09-04

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2020-09-04, terminated 2021-08-31. It names one FDA 510(k) clearance: K080361. Product: Biomet Regenerex Primary Taper Cap Item Number 141269. Reason: Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized.

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-09-04
Terminated: 2021-08-31
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K080361 — REGENEREX TIBIAL COMPONENTSBiomet, Inc.·cleared 2008-04-21

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

Biomet Regenerex Primary Taper Cap Item Number 141269

Reason for recall

Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized

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