FDAFDA · Food and drugs·Recall number Z-2616-2014
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.
Published September 17, 2014 · Recall initiated: June 14, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- PIONEER SURGICAL TECHNOLOGY, INC.
- Distributor
- Nationwide Distribution including TX, CA, IL, and FL.
- Lot
- Lot number: 148062, 148440
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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