BEUDAMED
    FDA Enforcement Class II Terminated

    SwishTapered Implant

    Recall: Z-1112-2017 · Reported February 8, 2017

    Enforcement

    Recall Number
    Z-1112-2017
    Event ID
    76111
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Implant Direct Sybron Manufacturing, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 8, 2017
    Initiation Date
    December 12, 2016
    Classification Date
    January 28, 2017
    Termination Date
    May 22, 2017
    Address
    3050 E Hillcrest Dr, N/A, Westlake Village, CA, 91362-3171, United States

    Description

    SwishTapered Implant

    Reason

    The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect position. This discrepancy may lead to the possibility of extender not seating properly on the implant, which may lead to micro-leakage and a possible infection to the patient.

    Code Info

    933308 Lot # 73241

    Distribution

    U.S. distribution to the following; NM, TX, CA, OR, OH, ME. Foreign distribution to the following; Netherlands.

    Quantity

    17