BEUDAMED
    FDA Enforcement Class II Terminated

    GIZA Vertebral Body Replacement

    Recall: Z-2072-2017 · Reported May 24, 2017

    Enforcement

    Recall Number
    Z-2072-2017
    Event ID
    76852
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Eden Spine Europe SA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 24, 2017
    Initiation Date
    March 17, 2017
    Classification Date
    May 12, 2017
    Termination Date
    January 6, 2020
    Address
    rue du 31 Decembre 41, Geneva, N/A, Switzerland

    Description

    GIZA Vertebral Body Replacement

    Reason

    Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw.

    Code Info

    Part # 48291482S Cage Giza Diam 14mm, 18-22 mm, 2-5 Deg GTIN 07640167930012 Part # 48291485S Cage Giza Diam 14mm, 18-22 mm, 5-8Deg GTIN 07640167930029 Part # 48291422S Cage Giza Diam 14mm, 23-32 mm, 2-5 Deg GTIN 07640167930036 Part # 48291427S Cage Giza Diam 14mm, 23-32 mm, 7-10 Deg GTIN 07640167930043 Part # 48291432S Cage Giza Diam 14mm, 33-54 mm, 2-5 Deg GTIN 07640167930050 and Part # 48291437S Cage Giza Diam 14mm, 33-54 mm, 7-10 Deg GTIN 07640167930067

    Distribution

    AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WY

    Quantity

    1,839