BEUDAMED
    FDA Enforcement Class II Terminated

    Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.

    Recall: Z-1829-2016 · Reported June 1, 2016

    Enforcement

    Recall Number
    Z-1829-2016
    Event ID
    74031
    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
    June 1, 2016
    Initiation Date
    April 22, 2016
    Classification Date
    May 26, 2016
    Termination Date
    February 8, 2017
    Address
    375 River Park Cir, N/A, Marquette, MI, 49855-1781, United States

    Description

    Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.

    Reason

    Potential for a product defect where the cannula may be obstructed. This obstruction could prevent a driver from going through, which increases the potential for the driver to slip, resulting in possible patient injury.

    Code Info

    Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve; Lot Number: 170684; Part Number: 26-COUNTER-T-XLINK

    Distribution

    US nationwide distribution in CA, FL, IN, MI, MO, NC, NY, and TX.

    Quantity

    17 devices