BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2657-2014 · Initiated August 28, 2014

    Recall

    Recall Number
    Z-2657-2014
    Event Number
    69113
    Firm
    Motion Concepts 84 Citation Drive Units 1-7 Concord Canada
    FEI Number
    3001045529
    Product Code
    ITI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 28, 2014
    Posted
    September 17, 2014
    Terminated
    June 3, 2015

    Description

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

    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).

    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.

    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.

    Quantity

    US: 59 units