Recall Z-2657-2014 ยท ITI Wheelchair, Powered
Motion Concepts
TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System.
| Date | Sep 17, 2014 (initiated Aug 28, 2014) |
| Status | Terminated |
| Reason | Motion Concepts identified that there is a possibility of knee support failure occurring through fatigue of two attachment bolts in the Vertical Position System (TRx Vertical Positioner). |
| Root cause | Device Design |
| Action | URGENT RECALL NOTIFICATION Letters (dated 8/26/2014) were sent to customers on 8/26/14 via Federal Express. Motion Concepts is requesting that all customers that have purchased a Motion Concepts TRx Vertical Positioner system in between June 2011 - May 2014 to make arrangements for replacement of the knee support mount in accordance with the instructions enclosed in the letter. For questions, please contact us at 905-695-0134. |
| Quantity | US: 59 units |
| Distribution | US Distribution in states of: AR, CA, CT, DE, IA, ID, IL, IN, MI, MD, MO, NE, NY, OH, PA, TN, TX, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023426 | TRX VERTICAL POSITIONER Motion Concepts, Nov 21, 2002 |