Recall Z-2362-2020— Biomet

Name: FDA recall Z-2362-2020
Creator: U.S. Food and Drug Administration
Published: 2020-05-01

Class II · Terminated

Class II FDA medical device recall by Biomet, initiated 2020-05-01, terminated 2021-07-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235. Reason: Device and tray that houses the device did not pass steam sterilization process validation testing.

Recalling firm: Biomet
Classification: Class II
Status: Terminated
Initiated: 2020-05-01
Terminated: 2021-07-28
Firm location: Miami, FL, United States

Product description

Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235

Reason for recall

Device and tray that houses the device did not pass steam sterilization process validation testing

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