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PIONEER SURGICAL TECHNOLOGY, INC. recalls Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation Syste
Recalled September 17, 2014 · FDA recall Z-2616-2014 · PIONEER SURGICAL TECHNOLOGY
Hazard
The affected fixed rod holders did not allow the instrument to lock down on the spinal rod. · FDA Class II
Units
9
Sold at
Nationwide Distribution including TX, CA, IL, and FL.
Description
The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.
Product
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.
Manufacturer(s)
PIONEER SURGICAL TECHNOLOGY, INC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →