BEUDAMED
    FDA Enforcement Class II Terminated

    AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet. Removable functional orthodontic appliances that are to modify the growth of the jaws in a prescribed growth pattern.

    Recall: Z-1314-2014 · Reported April 9, 2014

    Enforcement

    Recall Number
    Z-1314-2014
    Event ID
    67647
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Allesee Orthodontic Appliances
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 9, 2014
    Initiation Date
    February 24, 2014
    Classification Date
    April 1, 2014
    Termination Date
    August 23, 2014
    Address
    13931 Spring St, Po Box 725, Sturtevant, WI, 53177-1250, United States

    Description

    AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet. Removable functional orthodontic appliances that are to modify the growth of the jaws in a prescribed growth pattern.

    Reason

    The Lock Nut component of the Jet appliances may be missing the screw collar, which serves as a mechanical stop to prevent over-tightening in appliance assemby. Without this collar, an over-tightened lock nut may stop the piston assembly from moving freely, subsequently preventing intended movement of the teeth.

    Code Info

    All Devices/Codes Manufactured from August 28, 2013 to November 6, 2013

    Distribution

    Worldwide Distribution: US (nationwide) and the country of : Canada.

    Quantity

    411