BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker Reliance AL Implant Blocker (Various sizes) The SLIDE Implant Blocker is a reusable instrument, sterilized prior to use. It allows the surgeon to distract the disc space in the lumbar region of the spine using an anterior or anterolateral approach while also allowing them to insert the implant into final position.

    Recall: Z-2176-2012 · Reported August 15, 2012

    Enforcement

    Recall Number
    Z-2176-2012
    Event ID
    62415
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Spine
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 15, 2012
    Initiation Date
    March 21, 2011
    Classification Date
    August 9, 2012
    Termination Date
    March 21, 2013
    Address
    2 Pearl Ct, Allendale, NJ, 07401-1611, United States

    Description

    Stryker Reliance AL Implant Blocker (Various sizes) The SLIDE Implant Blocker is a reusable instrument, sterilized prior to use. It allows the surgeon to distract the disc space in the lumbar region of the spine using an anterior or anterolateral approach while also allowing them to insert the implant into final position.

    Reason

    Stryker Spine has received six reports regarding the breakage of one or more prongs at the extremity of the instrument.

    Code Info

    Catalog Number: 48361223, 48361224, 48361225, 48361226, 48361227, 48361228 Lot Code: 084505, 084506, 084507, 084508, 084509, 084510

    Distribution

    Nationwide Distribution including NC, AR, TN, MA, IL, GA, NY, LA, MN, MO, OH, KS, NM, TX, KS,and IN.

    Quantity

    109 Lots