Device product
Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003
Z-2363-2020
Product summary
- Firm
- Biomet
- Event
- Event 85641
- Status
- Terminated
- Classification
- Class II
- Quantity
- 705 units
- Official record key
device-enforcement:Z-2363-2020
Official wording
Reason: Device and tray that houses the device did not pass steam sterilization process validation testing
Code information: All lots
Distribution pattern: Nationwide Foreign: CHINA, AUSTRALIA, CHILE, COSTA RICA , NETHERLANDS, SWITZERLAND
Derived failure modes
-
Unknown
Device and tray that houses the device did not pass steam sterilization process validation testing