Device recall
Z-1030-2022: Restrata, Part Number RWM1-2X2
FDA device recall · Class II · Acera Surgical Inc
Key facts
| Recall number (Z-number) | Z-1030-2022 |
|---|---|
| Recall event | 89919 |
| Product | Restrata, Part Number RWM1-2X2 |
| Product code | FRO |
| Recalling firm | Acera Surgical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 20, 2024 |
| 510(k) numbers | K170300, K193583 |
| FEI number | 3012429393 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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