Z-2362-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 24, 2020
- Initiation Date
- May 1, 2020
- Termination Date
- July 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 136 units
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
Distribution Pattern
Nationwide Foreign: CHINA, AUSTRALIA, CHILE, COSTA RICA , NETHERLANDS, SWITZERLAND
Code Information
All lots