WalkAide Stimulator System Control Module, Part Number 20-0100; component of the WalkAide Stimulator System; distributed
FDA device recall Z-1435-2009 · posted 2009-06-03 · Terminated
Recall details
- Recalling firm
- Innovative Neurotronics, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- GZI
- Quantity affected
- 137 units
- Distribution
- Nationwide Distribution to the state of GA.
- Date initiated
- 2008-08-06
- Date posted
- 2009-06-03
- Date terminated
- 2009-07-28
- Location
- Austin, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000 (K052329) | Innovative Neurotronics, Inc. | 2005-09-21 |