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.
FDA Recall Z-1435-2009 · Posted 2009-06-03
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Recalling FirmInnovative Neurotronics, Inc.
Recall StatusTerminated
Product CodeGZI
Date Initiated2008-08-06
Date Terminated2009-07-28
Product Quantity137 units
Reason for Recall
Knob responsible for regulating the amount of stimulation administered by the WalkAide System control unit may fall off while device is in use.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution to the state of GA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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