Recall Z-0498-2009 ยท GZL Electrode, Depth
FHC, Inc.
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 stimulation of neural elements in the brain.
| Date | Dec 18, 2008 (initiated Oct 20, 2008) |
| Status | Terminated |
| Reason | Mislabeled: May contain an electrode longer than labeled size |
| Root cause | Pending |
| Action | FHC notified customers via an Urgent: Medical Device Recall letter dated 10/20/08 advising users to remove the recalled electrodes from inventory and set the product aside for inspection by your FHC representative. Customers were asked to document their actions by completing the enclosed form and faxing it back to FHC at 207-666-8539. |
| Quantity | 3 Kits (30 electrodes-10 electrodes/kit) |
| Distribution | Nationwide Distribution --- including states of CA, CO, FL, LA, NM, PA, TN, and PR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991522 | MICROTARGETING ELECTRODE FHC, Inc., Aug 4, 2000 |