BEUDAMED
    FDA Enforcement Class II Terminated

    GoDirect Screw-Retaining Top Part Numbers: 4500-61

    Recall: Z-0961-2017 · Reported January 18, 2017

    Enforcement

    Recall Number
    Z-0961-2017
    Event ID
    75838
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Implant Direct Sybron Manufacturing, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    January 18, 2017
    Initiation Date
    November 28, 2016
    Classification Date
    January 9, 2017
    Termination Date
    February 16, 2017
    Address
    3050 E Hillcrest Dr, Westlake Village, CA, 91362-3171, United States

    Description

    GoDirect Screw-Retaining Top Part Numbers: 4500-61

    Reason

    Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top.

    Code Info

    Lot #75808

    Distribution

    U.S. distribution to the following; WA. Foreign distribution to the following; Netherlands.

    Quantity

    14