Recall Z-2616-2014— PIONEER SURGICAL TECHNOLOGY, INC.

Name: FDA recall Z-2616-2014
Creator: U.S. Food and Drug Administration
Published: 2013-06-14

Class II · Terminated

Class II FDA medical device recall by PIONEER SURGICAL TECHNOLOGY, INC., initiated 2013-06-14, terminated 2014-09-30. It names one FDA 510(k) clearance: K130286. 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.. Reason: The affected fixed rod holders did not allow the instrument to lock down on the spinal rod..

Recalling firm: PIONEER SURGICAL TECHNOLOGY, INC.
Classification: Class II
Status: Terminated
Initiated: 2013-06-14
Terminated: 2014-09-30
Firm location: Marquette, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K130286 — STREAMLINE MIS SPINAL FIXATION SYSTEMPioneer Surgical Technology, Inc.·cleared 2013-04-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.