BEUDAMED
    FDA Enforcement Class II Terminated

    Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD

    Recall: Z-2125-2017 · Reported May 31, 2017

    Enforcement

    Recall Number
    Z-2125-2017
    Event ID
    77171
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Implant Direct Sybron Manufacturing, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 31, 2017
    Initiation Date
    May 2, 2017
    Classification Date
    May 22, 2017
    Termination Date
    January 8, 2018
    Address
    3050 E Hillcrest Dr, Westlake Village, CA, 91362-3171, United States

    Description

    Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD

    Reason

    Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification.

    Code Info

    89103, 83493, 78986

    Distribution

    Worldwide Distribution - Nationwide Distribution and to the countries of : European Union (HU, GB, DE, DK, IT, HR, FR), and Japan

    Quantity

    151 units