BEUDAMED
    FDA Enforcement Class II Terminated

    RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver

    Recall: Z-1393-2016 · Reported April 20, 2016

    Enforcement

    Recall Number
    Z-1393-2016
    Event ID
    73659
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 20, 2016
    Initiation Date
    March 18, 2016
    Classification Date
    April 14, 2016
    Termination Date
    September 12, 2016
    Address
    375 River Park Cir, N/A, Marquette, MI, 49855-1781, United States

    Description

    RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver

    Reason

    Multiple lots of the 26-FNLDRIVER, may have reduced mechanical strength, resulting in driver tip fracturing during use.

    Code Info

    26-FNLDRIVER, Lot Numbers: 177091, 177093, 183817, 207727, 223926, 227291, 229134, 230523, 232262, 233074, 234205

    Distribution

    Domestic: AL, CO, CT, FL, IN, ID, IL, MI, MS, MO, NC, NY, TX Foreign: None VA/DOD: None

    Quantity

    N/A