Device recall
Z-1028-2022: Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model…
FDA device recall · Class II · restor3d Inc.
Key facts
| Recall number (Z-number) | Z-1028-2022 |
|---|---|
| Recall event | 89983 |
| Product | Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument |
| Product code | LXH |
| Recalling firm | restor3d Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 28, 2023 |
| FEI number | 3014833750 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database