BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0942-2017 · Reported January 11, 2017

    Enforcement

    Recall Number
    Z-0942-2017
    Event ID
    75881
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pride Mobility Products Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 11, 2017
    Initiation Date
    December 1, 2016
    Classification Date
    January 3, 2017
    Termination Date
    March 19, 2020
    Address
    182 Susquehanna Ave, N/A, Exeter, PA, 18643-2653, United States

    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.

    Code Info

    Numerous serial numbers affected (12,343 units)

    Distribution

    Nationwide Distribution

    Quantity

    12,343 chairs