Recall Z-2363-2020— Biomet
Class II · Terminated
Class II FDA medical device recall by Biomet, initiated 2020-05-01, terminated 2021-07-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003. Reason: Device and tray that houses the device did not pass steam sterilization process validation testing.
- Recalling firm
- Biomet
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-05-01
- Terminated
- 2021-07-28
- Firm location
- Miami, FL, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.