FDA recall Z-2363-2020

Product

Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003

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-2363-2020