Device recall
Z-0416-2019: OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G
FDA device recall · Class II · AROA Biosurgery, LTD.
Key facts
| Recall number (Z-number) | Z-0416-2019 |
|---|---|
| Recall event | 81166 |
| Product | OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G |
| 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