FDA Device recall Z-1366-2022
Wright EVOLVE TRIAD Plate Cutter, REF 49510120
- FDA Device
- Class II
- ongoing
- Published 2022-07-20
On 2022-07-20 the FDA classified a Class II recall of Wright EVOLVE TRIAD Plate Cutter, REF 49510120 by Wright Medical Technology, citing the plate cutter is unable to meet sterilization requirements when it is sterilized in a double-wrapped configuration according to the Option 1 Steam Sterilization parameters deta….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1366-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-06-14 |
| Published | 2022-07-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Wright Medical Technology |
| Distribution | US |
Product
Wright EVOLVE TRIAD Plate Cutter, REF 49510120
Reason
The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-wrapped configuration according to the Option 1 Steam Sterilization parameters detailed in instructions for use
Identifiers
| code_info | Lot codes: 955401, 1168853, 1349302, 1956936, 2486857 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1366-2022%22
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