Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE Recalled by PIONEER SURGICAL TECHNOLOGY, INC. Due to The affected fixed rod holders did not allow...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact PIONEER SURGICAL TECHNOLOGY, INC. directly.
Affected Products
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.
Quantity: 9
Why Was This Recalled?
The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About PIONEER SURGICAL TECHNOLOGY, INC.
PIONEER SURGICAL TECHNOLOGY, INC. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report