BEUDAMED
    FDA Enforcement Class II Terminated

    Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants

    Recall: Z-0364-2020 · Reported November 20, 2019

    Enforcement

    Recall Number
    Z-0364-2020
    Event ID
    83763
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Implant Direct Sybron Manufacturing, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 20, 2019
    Initiation Date
    August 9, 2019
    Classification Date
    November 12, 2019
    Termination Date
    April 27, 2021
    Address
    3050 E Hillcrest Dr, N/A, Westlake Village, CA, 91362-3171, United States

    Description

    Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants

    Reason

    A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.

    Code Info

    Lot #135128 Exp: 3/12/20

    Distribution

    U.S.: IN, VA, MD, TX, WA OUS: Japan

    Quantity

    23 implants