BEUDAMED
    FDA Enforcement Class II Terminated

    HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 21 and HTH Mechanism Set Size 24 A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.

    Recall: Z-1507-2015 · Reported April 29, 2015

    Enforcement

    Recall Number
    Z-1507-2015
    Event ID
    70787
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Specialty Appliance Works, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2015
    Initiation Date
    March 9, 2015
    Classification Date
    April 22, 2015
    Termination Date
    January 12, 2017
    Address
    4905 Hammond Industrial Dr, Cumming, GA, 30041-3914, United States

    Description

    HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 21 and HTH Mechanism Set Size 24 A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.

    Reason

    The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.

    Code Info

    Product No. 90900, 90904, 90907, and 90910

    Distribution

    Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.

    Quantity

    14,428 Universal Nuts