FDA recall Z-2362-2020

Biomet · Class II · device

Product

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

Distribution

Nationwide Foreign: CHINA, AUSTRALIA, CHILE, COSTA RICA , NETHERLANDS, SWITZERLAND

Key facts

Status
Terminated
Initiation date
2020-05-01
Report date
2020-06-24
Termination date
2021-07-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2362-2020