BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0498-2009 · Initiated October 20, 2008

    Recall

    Recall Number
    Z-0498-2009
    Event Number
    50103
    Firm
    FHC, Inc.
    FEI Number
    3002250546
    Product Code
    GZL
    Status
    Terminated
    Root Cause
    Pending
    Initiated
    October 20, 2008
    Posted
    December 18, 2008
    Terminated
    May 2, 2012
    Address
    1201 Main Street, Bowdoinham, ME, 04008

    Description

    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.

    Reason

    Mislabeled: May contain an electrode longer than labeled size

    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.

    Distribution

    Nationwide Distribution --- including states of CA, CO, FL, LA, NM, PA, TN, and PR.

    Quantity

    3 Kits (30 electrodes-10 electrodes/kit)