Z-0498-2009

FC4000 MicroTargeting Electrode Kit 5x For use with Nexframe and Nexdrive Distributed by Medtronic Inc...

Name: Z-0498-2009 FC4000 MicroTargeting Electrode Kit 5x For use with Nexframe and Nexdrive Distributed by Medtronic Inc...
Creator: FHC, Inc.
Published: 2008-10-20
License: https://open.fda.gov/license/

FHC, Inc. / initiated 2008-10-20 / Terminated / root cause: labeling and UDI

FDA source

FHC, Inc. began a recall of FC4000 MicroTargeting Electrode Kit 5x For use with Nexframe and Nexdrive Distributed by Medtronic Inc., Minneapolis, MN REF: FCH 4000 (5 Prefilled single use... on 2008-10-20. The reason FDA records is "Mislabeled: May contain an electrode longer than labeled size". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0498-2009
Status: Terminated
Initiated: 2008-10-20
Posted: 2008-12-18
Terminated: 2012-05-02
Recalling firm: FHC, Inc.
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 stimulation of neural elements in the brain.
Product code: GZL Electrode, Depth
Reason for recall: Mislabeled: May contain an electrode longer than labeled size
Root cause tag: labeling and UDI
FDA 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 in commerce: 3 Kits (30 electrodes-10 electrodes/kit)
Distribution: Nationwide Distribution --- including states of CA, CO, FL, LA, NM, PA, TN, and PR.
Product codes and lots: Lot number: 866051

Product code GZL

K991522Class IIMicrotargeting ElectrodeFHC, Inc. / cleared 2000-08-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)