BEUDAMED
    FDA Recall Terminated

    Bond-1 Primer/Adhesive. The intended use of this device is adhesion to dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi-precious and non-precious alloys, porcelain and glass and luting of same to Dentin and Enamel.

    Recall: Z-1150-2010 · Initiated August 24, 2009

    Recall

    Recall Number
    Z-1150-2010
    Event Number
    54490
    Firm
    Sybron Dental Specialties
    FEI Number
    2024312
    Product Code
    KLE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 24, 2009
    Posted
    March 16, 2010
    Terminated
    February 24, 2012
    Address
    1717 W Collins Ave, Orange, CA, 92867-5422

    Description

    Bond-1 Primer/Adhesive. The intended use of this device is adhesion to dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi-precious and non-precious alloys, porcelain and glass and luting of same to Dentin and Enamel.

    Reason

    Some of the material has been found to be gelled and therefore becomes unusable.

    Action

    An "Urgent Medical Device Recall" letter and "Recall Return Form" were sent by first class mail on August 24, 2009 to consignees. The letter acknowledged the "gelling" issue of identified lots shipped between July 2009 & August 2009. Customers were requested to return any of the remaining affected lots in their inventory. Contact Customer Service by calling 1-800-551-0283, (option 1) directly to handle the arrangements of a quick return and replacement.

    Distribution

    Worldwide Distribution -- United States, Canada, Netherlands, Sweden, Taiwan and Thailand.

    Quantity

    1,400