Device recall
Z-2447-2010: PSD Gel that's provided with Peri-Strips Dry Staple Line Reinforcement with Apex…
FDA device recall · Class II · Synovis Surgical Inovation Div. of
Key facts
| Recall number (Z-number) | Z-2447-2010 |
|---|---|
| Recall event | 56327 |
| Product | PSD Gel that's provided with Peri-Strips Dry Staple Line Reinforcement with Apex Processing (PSD) and Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V) products. Sterile, Rx only, Synovis Surgical Innovations. Intended to be used as a staple line buttress. |
| Product code | DXZ |
| Recalling firm | Synovis Surgical Inovation Div. of |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 17, 2011 |
| 510(k) numbers | K040415 |
| FEI number | 2183620 |
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