Device recall
Z-0378-2019: Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template…
FDA device recall · Class II · AROA BIOSURGERY
Key facts
| Recall number (Z-number) | Z-0378-2019 |
|---|---|
| Recall event | 81161 |
| Product | Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment. |
| Product code | KGN |
| Recalling firm | AROA BIOSURGERY |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 9, 2019 |
| 510(k) numbers | K092096 |
| FEI number | 3007321028 |
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