BEUDAMED
    FDA Recall Terminated

    Allen Medical Systems PAL Pro Stirrups Catalog Number: A-10051-A1

    Recall: Z-0953-03 · Initiated June 2, 2003

    Recall

    Recall Number
    Z-0953-03
    Event Number
    26439
    Firm
    The OR Group, Inc. A Subsidiary of Hill-Rom Inc. One Post Office Square
    Product Code
    FWZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 2, 2003
    Posted
    June 27, 2003
    Terminated
    February 2, 2016
    Address
    Acton, MA, 01720

    Description

    Allen Medical Systems PAL Pro Stirrups Catalog Number: A-10051-A1

    Reason

    Foot Stirrups may detach from mount when user is locking system

    Action

    The OR Group notifed the accounts by letter sent Air Borne on 6/6/03 advising users to return the stirrups. The firm will inspect and repair the returned units. The firm expanded the recall to include units manufactured between August 02 and May 03. Recall letters were issued on 9/18/03 via Fed'X with instructions to test and identify the device for correct measurement.

    Distribution

    Nationwide Foreign: Australia, Korea, Italy, Hong Kong, Ireland, Czech republic, South Africa,

    Quantity

    460 units