Device recall
Z-1076-2015: The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm (01)…
FDA device recall · Class II · MAST Biosurgery USA, Inc
Key facts
| Recall number (Z-number) | Z-1076-2015 |
|---|---|
| Recall event | 70051 |
| Product | The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm (01) 18964050255027 (17) 170731(10)52804 LOT 52804 2017-08 REF25502-01 Product is wrapped in a foil pouch that is then sealed into an additional envelope. |
| Product code | FTL |
| Recalling firm | MAST Biosurgery USA, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 24, 2015 |
| 510(k) numbers | K061473 |
| FEI number | 3004661493 |
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