FDA Medical Device Recalls (openFDA)
Innovative Neurotronics, Inc.: 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 number
- Z-1435-2009
- 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.
- Status
- Terminated
- Initiated
- 2008-08-06
- Posted
- 2009-06-03
- Terminated
- 2009-07-28
- Reason
- 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
- 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
- 137 units
- Distribution
- Nationwide Distribution to the state of GA.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K052329"]
- PMA numbers
- not on file
- Product code
- GZI
- Firm FEI
- 3005694504
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28