FDA Device recall Z-1028-2022
Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818)
- FDA Device
- Class II
- terminated
- Published 2022-05-11
On 2022-05-11 the FDA classified a Class II recall of Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818) by Restor3d, citing during re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1028-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-30 |
| Published | 2022-05-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Restor3d |
| Distribution | US |
Product
Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument
Reason
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
Identifiers
| code_info | Model: 6101-22200818; Lot: 2022010035; UDI: 00840097501598 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1028-2022%22
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