Reported Sep 17, 2014 · Terminated
Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System…
Pioneer Surgical Technology, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PIONEER SURGICAL TECHNOLOGY, INC. · 375 River Park Cir · Marquette, MI · 49855-1781
Is this the product you have?
- 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 indicationsdegenerative 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
- Lot codes and dates
- Lot number
148062148440
- Lot number
- Amount recalled
- 9
Where it was sold
Why it was recalled
The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.
This product could cause temporary or reversible health problems — stop using it.
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