BEUDAMED
    FDA Recall Terminated

    TS Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS Crown Component 6UR (5/pk), TS Crown Component 4LR (5/pk), TS Crown Component 5LR (5/pk), TS Crown Component 6LR (5/pk), TS Crown Component 4UL (5/pk), TS Crown Component 5UL (5/pk), TS Crown Component 4LL (5/pk), TS Crown Component 5LL (5/pk), and TS Crown Component 6LL (5/pk) 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-1509-2015 · Initiated March 9, 2015

    Recall

    Recall Number
    Z-1509-2015
    Event Number
    70787
    Firm
    Specialty Appliance Works, Inc.
    FEI Number
    3004158247
    Product Code
    ECN
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 9, 2015
    Posted
    April 22, 2015
    Terminated
    January 12, 2017
    Address
    4905 Hammond Industrial Dr, Cumming, GA, 30041-3914

    Description

    TS Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS Crown Component 6UR (5/pk), TS Crown Component 4LR (5/pk), TS Crown Component 5LR (5/pk), TS Crown Component 6LR (5/pk), TS Crown Component 4UL (5/pk), TS Crown Component 5UL (5/pk), TS Crown Component 4LL (5/pk), TS Crown Component 5LL (5/pk), and TS Crown Component 6LL (5/pk) 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.

    Action

    Specialty Applicances sent an Urgent Voluntary Productionn Field Correction Notification dated March 9, 2015, to all affected customers who received the Herbst Appliances and for sales supply orders. The letter advised doctors to monitor the appliance during routine follow-up appointments for signs of corrosion, and for sales supply orders to return affected components to the lab for replacement. Customers were asked to complete and return the enclosed Field Correctivve Action Response Form and return via fax to 678-513-7345. To return affected devices call 800-522-4636 to receive instruction as to how to return it to Speciality Applicances. In the event that customers observe signs of corrosion or a fracture, they should contact customer service at 800-522-4636 or their sales representative. For questions customers should call 800-522-4636 For questions regarding this recall call 678-513-4408, ext 226.

    Distribution

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

    Quantity

    14,428 Universal Nuts