FDA Device recall Z-1169-2014
Contra-Angle Torque Driver Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing
- FDA Device
- Class II
- terminated
- Published 2014-03-19
On 2014-03-19 the FDA classified a Class II recall of Contra-Angle Torque Driver Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing by Biomet 3i, citing during recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1169-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-22 |
| Published | 2014-03-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet 3i |
| Distribution | US |
Product
Contra-Angle Torque Driver Kit 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.
Identifiers
| code_info | NCATDO aka CATD0 (PSDT1) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1169-2014%22
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