BEUDAMED
    FDA Enforcement Class II Terminated

    RePlant¿ Angled Abutment Part Number 6050-52-60

    Recall: Z-2320-2016 · Reported August 10, 2016

    Enforcement

    Recall Number
    Z-2320-2016
    Event ID
    74624
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Implant Direct Sybron Manufacturing, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 10, 2016
    Initiation Date
    July 5, 2016
    Classification Date
    August 2, 2016
    Termination Date
    February 16, 2017
    Address
    3050 E Hillcrest Dr, Westlake Village, CA, 91362-3171, United States

    Description

    RePlant¿ Angled Abutment Part Number 6050-52-60

    Reason

    Issue with design specification; oversized condition.

    Code Info

    Lot #50174, 39799, 49364

    Distribution

    U.S. distribution to the following; CA, WA, UT, GA, AZ, NE, OR, MI, TX, WI, FL, AL, AR, MO, VA, MA, TN, LA, NC, KS, NY, SC, OK. Foreign distribution to the following; CA, DE, IT, GB, PL, DE, GB, NL, GR, ES, HR, BG.

    Quantity

    205