PIONEER SURGICAL TECHNOLOGY, INC.: Medical Device Recall in 2014 - (Recall #: Z-2616-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product 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.

Product Classification:

Class II

Date Initiated: June 14, 2013

Date Posted: September 17, 2014

Recall Number: Z-2616-2014

Event ID: 69036

Reason for Recall:

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

Status: Terminated

Product Quantity: 9

Code Information:

Lot number: 148062, 148440

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated