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Z-1435-2009

WalkAide Stimulator System Control Module, Part Number 20-0100; component of the WalkAide Stimulator System...

Innovative Neurotronics, Inc. / initiated 2008-08-06 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

Innovative Neurotronics, Inc. began a recall of WalkAide Stimulator System Control Module, Part Number 20-0100; component of the WalkAide Stimulator System; distributed by Innovative Neurotronics, Austin, TX... on . The reason FDA records is "Knob responsible for regulating the amount of stimulation administered by the WalkAide System control unit may fall off while device is in use". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1435-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Innovative Neurotronics, Inc.
Product
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.
Product code
GZI Stimulator, Neuromuscular, External Functional
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.
Root cause tag
manufacturing process
FDA root cause
Nonconforming Material/Component
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.
Quantity in commerce
137 units
Distribution
Nationwide Distribution to the state of GA.
Product codes and lots
Serial Numbers: 161024, 161471, 161971, 162121, 162149, 163264, 163424, 163586, 163844, 164343, 164647, 164816, 165459, 166074, 166583, 166725, 167715, 167788, 170292, 170309, 170407, 170425, 170434, 170452, 170523, 170532, 170694, 170701, 170747, 170916, 171040, 171139, 171219, 171362, 171371, 171371, 222093, 222137, 222173, 222235, 222244, 222333, 222379, 222388, 222413, 222431, 222468, 222477, 222502, 222539, 222584, 222593, 222600, 168054, 168072, 168090, 168107, 168116, 168134, 168143, 168189, 168483, 168929, 169357, 169562, 169660, 169893, 170041, 170121, 170238, 220755, 220808, 220960, 221174, 221209, 221263, 221290, 221325, 221389, 221923, 221932, 221941, 221950, 221969, 222048, 222057, 222075, 167813, 167822, 167895, 167902, 167911, 167920, 167939, 167948, 167957, 167966, 167975, 167993, 168009, 168036, 222548, 222575, 167742, 172218, 172343, 203809, 204031, 204273, 204344, 204406, 204415, 204442, 205003, 205236, 208966, 220700, 220728, 169919, 169937, 171433, 222646, 222655, 222673, 222717, 222726, 222735, 222744, 222753, 222799, 222815, 222824, 222922, 222931, 222959, 221996, 222002 and 171442.