BEUDAMED
    FDA Enforcement Class II Terminated

    Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.

    Recall: Z-0007-2018 · Reported October 11, 2017

    Enforcement

    Recall Number
    Z-0007-2018
    Event ID
    77788
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Implant Direct Sybron Manufacturing, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 11, 2017
    Initiation Date
    July 21, 2017
    Classification Date
    October 3, 2017
    Termination Date
    April 1, 2021
    Address
    3050 E Hillcrest Dr, N/A, Westlake Village, CA, 91362-3171, United States

    Description

    Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.

    Reason

    The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component.

    Code Info

    Product Code 9048-13H, Lot No. 81080

    Distribution

    Distribution US nationwide including CA, FL, NJ, NY, PA, TX, & UT.

    Quantity

    50 units