Recall Z-0942-2017 ยท ITI Wheelchair, Powered
Pride Mobility Products Corp
TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). Mobility Medical Device
| Date | Jan 3, 2017 (initiated Dec 1, 2016) |
| Status | Terminated |
| Reason | The interface between the TB3 back and tilt base can separate when tilted beyond the specified angle. |
| Root cause | Use error |
| Action | Pride Mobility Products Corp. mailed a letter to affected customers to inform them of the issue. Systems were not required to be returned. Customers were informed that a TB3 Seat Depth Adjustment Reinformcement Kit which contains (2) reinforcement plates and associated hardware to strengthen the interface will be installed to address the issue. Direct accounts were asked to contact patients to inform them of the product correction. Customers were also requested to complete and return Pride's completion card once the correction has been made. Pride will issue a $65.00 credit once the comple |
| Quantity | 12,343 chairs |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041346 | SYNERGY ULTIMATE Pride Mobility Products Corp., Sep 8, 2004 |