BEUDAMED
    FDA Recall Terminated

    Artiste Maverick Tint, Part Number: N36TB, Lot/Serial Numbers: 3416180, Product Description and Intended Use: The intended use of this device is for internal color characterization and includes 3 opaques for blocking out deep staining or metal substrates. Product Usage: The intended use of this device is for internal color characterization and includes 3 opaques for blocking out deep staining or metal substrates.

    Recall: Z-0455-2012 · Initiated March 3, 2011

    Recall

    Recall Number
    Z-0455-2012
    Event Number
    60551
    Firm
    Kerr Corporation
    FEI Number
    2024312
    Product Code
    EMA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 3, 2011
    Posted
    January 11, 2012
    Terminated
    January 9, 2012
    Address
    1717 W Collins Ave, Orange, CA, 92867-5422

    Description

    Artiste Maverick Tint, Part Number: N36TB, Lot/Serial Numbers: 3416180, Product Description and Intended Use: The intended use of this device is for internal color characterization and includes 3 opaques for blocking out deep staining or metal substrates. Product Usage: The intended use of this device is for internal color characterization and includes 3 opaques for blocking out deep staining or metal substrates.

    Reason

    The resin material separates when the product is extruded from the syringe. Although there are no safety issues related with this situation, please refrain from using the affected product.

    Action

    Pentron Clinical sent an URGENT: Medical Device Recall letter dated April 20, 2011 to all affected customers. The letter described the product, problem and actions to be taken. Customers were instructed to examine their inventory and quarantine all product(s) subject to recall for return and exchange at no charge. In addition, the letter states that if the product was further distributed to contact their customers and notify them of the recall. Customers were also asked to complete and return the enclosed Recall Return Form. Contact Pentron Clinical Customer Service at (800) 551-0283, (option 1) directly to handle the arrangement of a quick return and replacement.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of: Armenia, Russia and Ukraine.

    Quantity

    100 Units