Recall Z-1435-2009 ยท GZI Stimulator, Neuromuscular, External Functional
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.
| Date | Jun 3, 2009 (initiated Aug 6, 2008) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052329 | WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000 Innovative Neurotronics, Inc., Sep 21, 2005 |