BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2657-2014 · Reported September 24, 2014

    Enforcement

    Recall Number
    Z-2657-2014
    Event ID
    69113
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Motion Concepts
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 24, 2014
    Initiation Date
    August 28, 2014
    Classification Date
    September 17, 2014
    Termination Date
    June 3, 2015
    Address
    84 Citation Drive, Units 1-7, Concord, N/A, N/A, Canada

    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).

    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.

    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