BEUDAMED
    FDA Recall Terminated

    Sealapex Express (Part Number: 33639), root canal filling material. Manufactured by SybronEndo, Glendora, CA. Intended as a root canal filling material that is used in conjunction with gutta percha or silver endodontic points.

    Recall: Z-0917-2010 · Initiated February 23, 2009

    Recall

    Recall Number
    Z-0917-2010
    Event Number
    53480
    Firm
    Sybron Dental Specialties
    FEI Number
    2024312
    Product Code
    KIF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 23, 2009
    Posted
    March 2, 2010
    Terminated
    March 21, 2012
    Address
    1717 W Collins Ave, Orange, CA, 92867-5422

    Description

    Sealapex Express (Part Number: 33639), root canal filling material. Manufactured by SybronEndo, Glendora, CA. Intended as a root canal filling material that is used in conjunction with gutta percha or silver endodontic points.

    Reason

    Sybron Dental Specialties is initiating a recall on the Sealapex Xpress due to the presence of crystals in the catalyst. This crystallization may affect proper canal filling by preventing Gutta Percha Points from reaching the bottom of the root canal which may lead to an inadequate seal.

    Action

    SybronEndo initiated an "Urgent Medical Device Recall" notification dated February 19 , 2009. Consignees were instructed to complete a "return form" and return any affected product in their inventory to the firm. Any product returned will be replaced at no charge. For further information, contact SybronEndo Customer Care at 1-800-346-3636.

    Distribution

    Worldwide Distribution -- United States, Australia, Canada, United Arab Emirates, Belgium, Bulgaria, Germany, Spain, France, UK, Greece, Italy, Kuwait, Lebanon, Portugal, Russia, Sweden, Hong Kong, India, Malaysia and Taiwan.

    Quantity

    1309 units