Device recall
Z-0429-2019: OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
FDA device recall · Class II · AROA Biosurgery, LTD.
Key facts
| Recall number (Z-number) | Z-0429-2019 |
|---|---|
| Recall event | 81166 |
| Product | OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G |
| Product code | FTM |
| Recalling firm | AROA Biosurgery, LTD. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 15, 2019 |
| 510(k) numbers | K153633 |
| FEI number | 3007321028 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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