Recall Z-1653-2020— Biomet, Inc.

Name: FDA recall Z-1653-2020
Creator: U.S. Food and Drug Administration
Published: 2020-02-26

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2020-02-26, terminated 2021-07-29. It names one FDA 510(k) clearance: K052990. Product: BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.. Reason: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-02-26
Terminated: 2021-07-29
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K052990 — STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEMBiomet, Inc.·cleared 2005-12-16

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 StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

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