Device recall
Z-0498-2009: FC4000 MicroTargeting Electrode Kit 5x For use with Nexframe and Nexdrive…
FDA device recall · Class II · FHC, Inc.
Key facts
| Recall number (Z-number) | Z-0498-2009 |
|---|---|
| Recall event | 50103 |
| Product | FC4000 MicroTargeting Electrode Kit 5x For use with Nexframe and Nexdrive Distributed by Medtronic Inc., Minneapolis, MN REF: FCH 4000 (5 Prefilled single use kits -5 packages and 2 electrodes each) Intended for use in intra-operative recording of single unit neuronal activity or intra-operative… |
| Product code | GZL |
| Recalling firm | FHC, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 2, 2012 |
| 510(k) numbers | K991522 |
| FEI number | 3002250546 |
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