Device product
Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235
Z-2362-2020
Product summary
- Firm
- Biomet
- Event
- Event 85641
- Status
- Terminated
- Classification
- Class II
- Quantity
- 136 units
- Official record key
device-enforcement:Z-2362-2020
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