BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1829-2016 · Initiated April 22, 2016

    Recall

    Recall Number
    Z-1829-2016
    Event Number
    74031
    Firm
    RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
    FEI Number
    1000115331
    Product Code
    KWP
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    April 22, 2016
    Posted
    May 26, 2016
    Terminated
    February 8, 2017
    Address
    375 River Park Cir, Marquette, MI, 49855-1781

    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.

    Action

    RTI sent an Urgent Voluntary Product Notification dated April 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. RTI Surgical is conducting a voluntary recall of the Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve due to the 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. For further questions, please call (906) 226-4489.

    Distribution

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

    Quantity

    17 devices