BEUDAMED
    FDA Enforcement Class II Terminated

    Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all the following indications: degenerative disc disease (ODD) (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and /or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Streamline MIS instrumentation, when used with the Streamline MIS Spinal Fixation System, is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

    Recall: Z-2616-2014 · Reported September 17, 2014

    Enforcement

    Recall Number
    Z-2616-2014
    Event ID
    69036
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    PIONEER SURGICAL TECHNOLOGY, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 17, 2014
    Initiation Date
    June 14, 2013
    Classification Date
    September 9, 2014
    Termination Date
    September 30, 2014
    Address
    375 River Park Cir, N/A, Marquette, MI, 49855-1781, United States

    Description

    Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all the following indications: degenerative disc disease (ODD) (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and /or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Streamline MIS instrumentation, when used with the Streamline MIS Spinal Fixation System, is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

    Reason

    The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.

    Code Info

    Lot number: 148062, 148440

    Distribution

    Nationwide Distribution including TX, CA, IL, and FL.

    Quantity

    9