BEUDAMED
    FDA Enforcement Class II Terminated

    Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intended to be used during endodontic therapy to fill the root canal of a tooth.

    Recall: Z-2836-2016 · Reported September 28, 2016

    Enforcement

    Recall Number
    Z-2836-2016
    Event ID
    75114
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ormco/Sybronendo
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 28, 2016
    Initiation Date
    August 31, 2016
    Classification Date
    September 16, 2016
    Termination Date
    September 1, 2017
    Address
    1332 S Lone Hill Ave, Glendora, CA, 91740-5339, United States

    Description

    Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intended to be used during endodontic therapy to fill the root canal of a tooth.

    Reason

    SybronEndo is recalling the Sealapex Xpress because it was labeled with an incorrect expiration date of 2017-11 while the syringe was labeled with the correct expiration date of 2016-11.

    Code Info

    lot # 5-1310

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Mexico, Belgium, Denmark, Germany, Great Britain, and Sweden.

    Quantity

    179 units