Device recall
Z-0478-2010: Protg EverFlex" Self-Expanding Biliary Stent System (for United States…
FDA device recall · Class II · Ev3, Inc.
Key facts
| Recall number (Z-number) | Z-0478-2010 |
|---|---|
| Recall event | 53867 |
| Product | Protg EverFlex" Self-Expanding Biliary Stent System (for United States distribution). 6 x 150mm, Model # PRB35-06-150-080. Sterile EO, ev3 Inc, 4600 Nathan lane North, Plymouth, MN 55442-2920, Rx only. Protg EverFlex" Self-Expanding Peripheral Stent System (for Outside United States distribution). 6… |
| Product code | FGE |
| Recalling firm | Ev3, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 8, 2012 |
| 510(k) numbers | K060057 |
| FEI number | 2183870 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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