Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2657-2014Class II

TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System

Motion Concepts LP / initiated 2014-08-28 / Terminated / root cause: design

Motion Concepts began a recall of TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System on . FDA classified it as Class II and gives the reason as "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)". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2657-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Motion Concepts LP
Product
TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System.
Product code
ITI Wheelchair, Powered
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).
Root cause tag
design
FDA 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 in commerce
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.
Product codes and lots
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.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2657-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2657-2014Class IITerminatedVoluntary: Firm initiated