BEUDAMED
    FDA Enforcement Class II Terminated

    Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,

    Recall: Z-1157-2020 · Reported February 19, 2020

    Enforcement

    Recall Number
    Z-1157-2020
    Event ID
    84777
    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 19, 2020
    Initiation Date
    October 11, 2019
    Classification Date
    February 12, 2020
    Termination Date
    April 12, 2024
    Address
    3050 E Hillcrest Dr, Westlake Village, CA, 91362-3171, United States

    Description

    Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,

    Reason

    Through a customer complaint and and internal investigation it was determined that some implant packages contain the incorrect cover screw and extender. This could result in delay in surgery and/or a potential new surgical procedures to place the correct parts. The level of severity varies based on a one or two stage surgery.

    Code Info

    Lot # 68209

    Distribution

    US: AR, AZ, CA, ID, IL, IN, KY, MD, ND, NH, NJ, NV, NY, Oh, OR, PA, TX, UT, WA, WI, WV, GA,MO

    Quantity

    78 implants