Recall Z-0497-2009 ยท GZL Electrode, Depth
FHC, Inc.
FHC MicroTargeting Electrode, MTDWBP(AR)(MP I ) 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 | 36 units (180 Electrodes-5 per package) |
| 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 |