BEUDAMED
    FDA Recall Terminated

    WalkAide Stimulator System Control Module, Part Number 20-0100; component of the WalkAide Stimulator System; distributed by Innovative Neurotronics, Austin, TX 78746. The WalkAide is a battery operated, single channel electrical stimulator that is used to improve walking ability by stimulating a foot lift at the appropriate time during the step cycle.

    Recall: Z-1435-2009 · Initiated August 6, 2008

    Recall

    Recall Number
    Z-1435-2009
    Event Number
    52049
    Firm
    Innovative Neurotronics, Inc.
    FEI Number
    3005694504
    Product Code
    GZI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 6, 2008
    Posted
    June 3, 2009
    Terminated
    July 28, 2009
    Address
    3600 North Capital of Texas Hwy, Bldg B Ste 150, Austin, TX, 78746

    Description

    WalkAide Stimulator System Control Module, Part Number 20-0100; component of the WalkAide Stimulator System; distributed by Innovative Neurotronics, Austin, TX 78746. The WalkAide is a battery operated, single channel electrical stimulator that is used to improve walking ability by stimulating a foot lift at the appropriate time during the step cycle.

    Reason

    Knob responsible for regulating the amount of stimulation administered by the WalkAide System control unit may fall off while device is in use.

    Action

    Innovative Neurotronics Inc notified the consignee via e-mail on August 6, 2008 of the affected product. The Consignee was asked to place a stop shipment on the WalkAides and to return inventory for replacement. Further questions can be directed to Innovative Neurotronics Inc at 1-512-721-1906.

    Distribution

    Nationwide Distribution to the state of GA.

    Quantity

    137 units