BEUDAMED
    FDA Enforcement Class II Terminated

    ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

    Recall: Z-0010-2020 · Reported October 9, 2019

    Enforcement

    Recall Number
    Z-0010-2020
    Event ID
    83086
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Implant Direct Sybron Manufacturing, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 9, 2019
    Initiation Date
    August 7, 2018
    Classification Date
    October 1, 2019
    Address
    3050 E Hillcrest Dr, N/A, Westlake Village, CA, 91362-3171, United States

    Description

    ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

    Reason

    The incorrect device was packaged in the vial.

    Code Info

    Lot 108191, UDI (01)10841307108313(17)230118(10)108191

    Distribution

    Distribution was made to AL, AZ, CA, CO, CT, FL, GA, ID, IL KY, MA, MD, NM, NV, NY, PA, and TX. There was no government/military distribution. Foreign distribution was made to Germany, Great Britain, Italy, Spain, Trinidad & Tobago, and UAE.

    Quantity

    158 devices