FDA Device recall Z-1167-2014
Navigator Surgical 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 Navigator Surgical 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-1167-2014 |
| 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
Navigator Surgical 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 | SGKIT (SGTRAY) |
|---|
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-1167-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.