BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head Monoaxial and closed head Polyaxial screws into the Ilium. Orthopedic manual surgical instrument.

    Recall: Z-0893-2013 · Reported March 6, 2013

    Enforcement

    Recall Number
    Z-0893-2013
    Event ID
    64313
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Spine
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 6, 2013
    Initiation Date
    December 27, 2012
    Classification Date
    February 28, 2013
    Termination Date
    September 30, 2015
    Address
    2 Pearl Ct, N/A, Allendale, NJ, 07401-1611, United States

    Description

    Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head Monoaxial and closed head Polyaxial screws into the Ilium. Orthopedic manual surgical instrument.

    Reason

    Surgeons have experienced unthreading of the screwdrivers outer shafts during use.

    Code Info

    Catalog Number: 48231326. Lot Number: 10G637; 10G638 and 10E852.

    Distribution

    Nationwide Distribution including the states of AL, AZ, CA, CO, FL, GA, IA, IL,IN, KS, LA, MA, MD, MI, MO, MN, NC, NY. OH, OK, OR, PA, TN, TX, UT and WI.

    Quantity

    46 units US