BEUDAMED
    FDA Recall Terminated

    ReTurn 7500/7500 Aid, transfer

    Recall: Z-0303-2017 · Initiated April 15, 2014

    Recall

    Recall Number
    Z-0303-2017
    Event Number
    75404
    Firm
    Handicare USA, Inc.
    FEI Number
    3007802293
    Product Code
    IKX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 15, 2014
    Terminated
    December 13, 2016
    Address
    2201 Hangar Pl, Ste 200, Allentown, PA, 18109-9342

    Description

    ReTurn 7500/7500 Aid, transfer

    Reason

    During the period of April 2009 May 2011, Handicare AB used a wing handle in which the screw and handle, after repeated tightening, may slide apart. This causes a small amount of play in the attachment of the ladder, which in turn results in high load at the attachment holes of the ladder. Eventually, this may cause mechanical fatigue in the material of the ladder.

    Action

    Handicare sent a Field Safety notice dated April 21, 2014, to all affected customers. The notification instructed customers to examine the affected ReTurn units for signs of wear and to complete the response form that was mailed with the customer notification letter indicating whether additional parts were required to complete the field correction. For further questions, please call (717) 733-1444.

    Distribution

    US Distribution to the states of : NY, NJ, NV, NE, IL, CT, PA and ME

    Quantity

    29 units , plus 47 wing handles were shipped as spare parts