Recall Z-1170-2014— Biomet 3i, LLC
Class II · Terminated
Class II FDA medical device recall by Biomet 3i, LLC, initiated 2013-07-22, terminated 2015-04-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Contra-Angle Torque Driver Kit For Certain Internal Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.. Reason: During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required..
- Recalling firm
- Biomet 3i, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-22
- Terminated
- 2015-04-21
- Firm location
- Palm Beach Gardens, FL, United States
Product description
Contra-Angle Torque Driver Kit For Certain Internal Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
Reason for recall
During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
Data sourced from openFDA. This site is unofficial and independent of the FDA.