BEUDAMED
    FDA Enforcement Class II Terminated

    The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. GoDirect Implants Part Number: 423011, 423013, 424708, 424710, 424713,433010,433710

    Recall: Z-1267-2016 · Reported April 6, 2016

    Enforcement

    Recall Number
    Z-1267-2016
    Event ID
    73448
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Implant Direct Sybron Manufacturing, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 6, 2016
    Initiation Date
    March 4, 2016
    Classification Date
    March 28, 2016
    Termination Date
    May 17, 2016
    Address
    3050 E Hillcrest Dr, N/A, Westlake Village, CA, 91362-3171, United States

    Description

    The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. GoDirect Implants Part Number: 423011, 423013, 424708, 424710, 424713,433010,433710

    Reason

    Implant Direct Sybron Manufacturing, LLC is recalling GoDirect Implants because some consignees did not receive the correct tool to drive the implant to bone level.

    Code Info

    Lot Number: 29707, 29708, 29709, 32444, 37438, 38159, 39506, 40394, 40542, 44661, 46030, 50644, 50824, 51092, 51249, 52798, 54274, 54275, 54617, 55407,60158

    Distribution

    Worldwide Distribution - Nationwide Distribution to the states of : FL, AZ, IL, MS, TX, CA, ID, AL, MO, MN, NY, CO, GA, ME, NJ, NC, NV, LA, KS, MN, KY, PA, UT, OH, MI, SC, MD, WA, WI., and to the countries of : Canada, Honduras and Dominican Republic.

    Quantity

    2033