Device recall
Z-1162-2010: SilverHawk Peripheral Cutter Driver Plaque Excision System REF Catalog No: FG…
FDA device recall · Class II · Ev3, Inc.
Key facts
| Recall number (Z-number) | Z-1162-2010 |
|---|---|
| Recall event | 52299 |
| Product | SilverHawk Peripheral Cutter Driver Plaque Excision System REF Catalog No: FG 02550, Sterilized with gamma radiation, Manufacturer ev3 Inc. 4600 Nathan Lane North, Plymouth, MN 55442, Manufactured at : 9775 Toledo Way, Irvine, CA 92618., Intended for use in atherectomy of the peripheral vasculature… |
| Product code | MCW |
| Recalling firm | Ev3, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 26, 2012 |
| 510(k) numbers | K061188 |
| FEI number | 2183870 |
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