TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System.
This recall has been terminated (originally issued September 17, 2014).
- Recall Initiated
- August 28, 2014
- Posted
- September 17, 2014
- Terminated
- June 3, 2015
- Recall Number
- Z-2657-2014
- Quantity
- US: 59 units
- Official Source
- View on FDA website ↗
Reason for Recall
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).
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.
Lot / Code Info
All units manufactured between June 2011 and May 2014: Serial Numbers 28583, 28597, 28604, 28607, 28629, 30334, 028380, U001050, U001083, U001544, U002020, U002326, U002386, U002403, U002411, U002489, U002502, U002505, U002509, U002510, U002519, U002716, U002922, U003577, U004011, U004018, U004073, U004079, U004145, U004214, U004400, U004404, U004472, U004485, U006042, U006234, U006235, U006260, U006295, U006296, U006353, U006378, U007126, U007138, U007163, U007239, U007245, U007279, U007288, U007407, U008556, U008631, U008698, U008840, U008896, U009548, U009569, U009579, U009707, U009718.
Root Cause
Device Design
Action Taken
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.