BEUDAMED
    FDA Recall Terminated

    AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functional appliances that are to modify the growth of the jaws in a prescribed growth pattern, however, this category is generally attached to the patients upper and lower molars or bicuspids by means of temporary stainless steel crowns or orthodontic bands. Retainer, Screw Expansion, Orthodontic.

    Recall: Z-2195-2013 · Initiated June 6, 2013

    Recall

    Recall Number
    Z-2195-2013
    Event Number
    66110
    Firm
    Sybron Dental Specialties
    FEI Number
    2024312
    Product Code
    DYJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 6, 2013
    Posted
    September 12, 2013
    Terminated
    September 13, 2013
    Address
    1717 W Collins Ave, Orange, CA, 92867-5422

    Description

    AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functional appliances that are to modify the growth of the jaws in a prescribed growth pattern, however, this category is generally attached to the patients upper and lower molars or bicuspids by means of temporary stainless steel crowns or orthodontic bands. Retainer, Screw Expansion, Orthodontic.

    Reason

    The firm initiated the recall of AOA Mini RPE Screw Assembly, because it may be missing a complete weld joining one side of the arm with the screw body. Herbst, MARA and Fixed Metal devices may be affected, because they contain an AOA Mini RPE Screw Assembly.

    Action

    AOA sent a recall notification letter titled "Urgent-Medical Device Correction", on June 6, 2013 via USPS 1st class mail. The letter identified the affected product, reason for recall, images, and actions to be taken. Customers were instructed to complete and return the attached Acknowledgement Form to AOA. For questions contact the AOA Customer Support Department at 1-800-262-2551.

    Distribution

    Worldwide Distribution - USA Nationwide and the countries of Australia, Canada, and EU.

    Quantity

    1,091