Device recall
Z-0707-06: ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System--- Sterilization…
FDA device recall · Class II · Ev3, Inc
Key facts
| Recall number (Z-number) | Z-0707-06 |
|---|---|
| Recall event | 34858 |
| Product | ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System--- Sterilization with Ethylene Oxide Gas. ev3, 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. The self-expanding stent is made of nickel titanium alloy (Nitinol) and comes pre-mounted on an over-the-wire delivery system. The stent is… |
| Product code | FGE |
| Recalling firm | Ev3, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 26, 2006 |
| 510(k) numbers | K011806 |
| 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