Recall Z-1670-2020— Biomet, Inc.

Name: FDA recall Z-1670-2020
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. FDA's recall record names no specific 510(k) clearance for this event. Product: BIOMET Custom StageOne Hip Femoral Reinforcement, 9 X 125 MM, Stainless Steel, PMI Instrument, Sterile, Item CP161972.. 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

Product description

BIOMET Custom StageOne Hip Femoral Reinforcement, 9 X 125 MM, Stainless Steel, PMI Instrument, Sterile, Item CP161972.

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.