Z-2363-2020 Class II Terminated
FDA device recall Z-2363-2020 was initiated by Biomet on May 1, 2020 and is designated Class II. Reason for recall: Device and tray that houses the device did not pass steam sterilization process validation testing The recall status is terminated (terminated July 28, 2021). Affected quantity: 705 units.
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
- 705 units
Product Description
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 Pattern
Nationwide Foreign: CHINA, AUSTRALIA, CHILE, COSTA RICA , NETHERLANDS, SWITZERLAND
Code Information
All lots