Device recall
Z-0794-2013: SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for…
FDA device recall · Class II · Allergen Medical
Key facts
| Recall number (Z-number) | Z-0794-2013 |
|---|---|
| Recall event | 64069 |
| Product | SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures. |
| Product code | FTL |
| Recalling firm | Allergen Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 29, 2013 |
| 510(k) numbers | K080442 |
| FEI number | 3008374097 |
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