BEUDAMED
    FDA Recall Terminated

    SwishTapered Implant Intended for use in support for fixed bridgework.

    Recall: Z-1167-2018 · Initiated January 19, 2018

    Recall

    Recall Number
    Z-1167-2018
    Event Number
    79396
    Firm
    Implant Direct Sybron Manufacturing, LLC
    FEI Number
    3001617766
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 19, 2018
    Terminated
    July 26, 2023
    Address
    3050 E Hillcrest Dr, Westlake Village, CA, 91362-3171

    Description

    SwishTapered 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).

    Action

    Customers were sent Urgent: Safety Alert/Advisory Notice letters around 01/19/2018. The Notice identified the affected device and the reason for the correction. Instructions for both distributors and doctors include to review inventory for affected product, complete and return the Acknowledgement form within 48 hours of receipt of the letter, follow the included instructions to correct the affected product, and distributors are to notify those customers that may have been shipped the affected product lot and inform them of the issue. Questions should be directed to Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425.

    Distribution

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

    Quantity

    1,117 units total