BEUDAMED
    FDA Enforcement Class II Terminated

    SwishPlus Implant Intended for use in support for fixed bridgework.

    Recall: Z-1168-2018 · Reported March 28, 2018

    Enforcement

    Recall Number
    Z-1168-2018
    Event ID
    79396
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Implant Direct Sybron Manufacturing, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 28, 2018
    Initiation Date
    January 19, 2018
    Classification Date
    March 22, 2018
    Termination Date
    July 26, 2023
    Address
    3050 E Hillcrest Dr, N/A, Westlake Village, CA, 91362-3171, United States

    Description

    SwishPlus Implant Intended for use in support for fixed bridgework.

    Reason

    The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer).

    Code Info

    Part No. (Lot No.): 924108 (97347), 924112 (64927, 93563, 98662), 924116 (70543), 924806 (99749), 924810W (93934), 924812W (94204), and 924814 (103199).

    Distribution

    Worldwide Distribution -- US, Europe, Canada, Australia, and Japan.

    Quantity

    1,117 units total