BEUDAMED
    FDA Recall Terminated

    microTargeting Drive DBS Lead Holder 66-CN-DB Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Drives are intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.

    Recall: Z-0313-2011 · Initiated March 30, 2010

    Recall

    Recall Number
    Z-0313-2011
    Event Number
    55287
    Firm
    FHC, Inc.
    FEI Number
    3002250546
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 30, 2010
    Posted
    November 3, 2010
    Terminated
    February 25, 2015
    Address
    1201 Main Street, Bowdoinham, ME, 04008

    Description

    microTargeting Drive DBS Lead Holder 66-CN-DB Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Drives are intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.

    Reason

    Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead.

    Action

    FHC issued an "URGENT: MEDICAL DEVICE CORRECTION" letter dated March 29, 2010, to all customers. The letter described the product, problem and actions to be taken by the customers. FHC informed the customers that that they had returned to the original design of the fixation screw in the Depth Stop Adapter. FHC sent replacement Depth Stop Adapter with an original fixation screw. The customers were instructed to discard the recalled Depth Stop Adapter (s) and replace with the enclosed corrected version(s) and sign and fax the receipt notification to 207-666-8309 as proof of their receipt of notification. For assistance with the product replacement, contact the FHC's technical support line at 800-326-2905. This line is staffed 24 hours a day. Should you have any further questions regarding this matter, please contact Dorothee Sasse, product manager, or Keri Seitz, recall coordinator at 207-666-8190.

    Distribution

    Worldwide distribution: USA in the states of AZ, CA, FL, ID, NC, MA, MI, MN, NV, RI, UT, VA, and WA, and countries of Columbia and South Africa.

    Quantity

    1