BEUDAMED
    FDA Enforcement Class II Terminated

    REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60

    Recall: Z-2376-2018 · Reported July 11, 2018

    Enforcement

    Recall Number
    Z-2376-2018
    Event ID
    80281
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Implant Direct Sybron Manufacturing, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 11, 2018
    Initiation Date
    May 18, 2018
    Classification Date
    July 5, 2018
    Termination Date
    July 13, 2020
    Address
    3050 E Hillcrest Dr, Thousand Oaks, CA, 91362, United States

    Description

    REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60

    Reason

    Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant

    Code Info

    Lot numbers: 45353, 66011, and 75850

    Distribution

    CA, FL, GA, IL, LA, MI, MT, NC, NJ, NY, OK, OR, SC, SD, TN & WA; International: Jordan, Great Britain, Germany, Spain, Italy & Poland

    Quantity

    60 units