BEUDAMED
    FDA Recall Terminated

    TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). Mobility Medical Device

    Recall: Z-0942-2017 · Initiated December 1, 2016

    Recall

    Recall Number
    Z-0942-2017
    Event Number
    75881
    Firm
    Pride Mobility Products Corp
    FEI Number
    3005068474
    Product Code
    ITI
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    December 1, 2016
    Posted
    January 3, 2017
    Terminated
    March 19, 2020
    Address
    182 Susquehanna Ave, Exeter, PA, 18643-2653

    Description

    TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). Mobility Medical Device

    Reason

    The interface between the TB3 back and tilt base can separate when tilted beyond the specified angle.

    Action

    Pride Mobility Products Corp. mailed a letter to affected customers to inform them of the issue. Systems were not required to be returned. Customers were informed that a TB3 Seat Depth Adjustment Reinformcement Kit which contains (2) reinforcement plates and associated hardware to strengthen the interface will be installed to address the issue. Direct accounts were asked to contact patients to inform them of the product correction. Customers were also requested to complete and return Pride's completion card once the correction has been made. Pride will issue a $65.00 credit once the completion card is received. Customers with questions were instructed to call Pride's Upgrade Department at 866-222-6212. For questions regarding this recall call 800-800-8586.

    Distribution

    Nationwide Distribution

    Quantity

    12,343 chairs