BEUDAMED
    FDA Enforcement Class II Terminated

    Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasive medical devices designed to attach to orthopedic fracture tables to aid clinical staff in applying traction to the leg of a patient during surgical procedures.

    Recall: Z-0959-2013 · Reported March 27, 2013

    Enforcement

    Recall Number
    Z-0959-2013
    Event ID
    64509
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Allen Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 27, 2013
    Initiation Date
    February 28, 2013
    Classification Date
    March 18, 2013
    Termination Date
    August 7, 2013
    Address
    One Post Office Square, N/A, Acton, MA, 01720, United States

    Description

    Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasive medical devices designed to attach to orthopedic fracture tables to aid clinical staff in applying traction to the leg of a patient during surgical procedures.

    Reason

    Some units may have been assembled incorrectly which could result in the boot breaking free from the mounting base and allowing the patient's leg to fall.

    Code Info

    A260264, A253312, A260989, A260262, 418292, A260991, A260998, A253313, A260993, A260265, 418293, A253309, A260995, A253310, A260992, A253311, 418294, A253323, A260261, A253321, A260994, 418291, 418295, A253322

    Distribution

    Worldwide Distribution- USA including the states of TX, NV, KY, GA, OH, PA, NY, AL, WA, IL and the countries of New Zealand and Japan.

    Quantity

    24 devices