Z-2616-2014Class II

Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal...

Name: Z-2616-2014 Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal...
Creator: Pioneer Surgical Technology, Inc.
Published: 2013-06-14
License: https://open.fda.gov/license/

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) / initiated 2013-06-14 / Terminated / root cause: design

FDA source

PIONEER SURGICAL TECHNOLOGY, INC. began a recall of Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for posterior, noncervical... on 2013-06-14. FDA classified it as Class II and gives the reason as "The affected fixed rod holders did not allow the instrument to lock down on the spinal rod". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2616-2014
Classification: Class II
Status: Terminated
Initiated: 2013-06-14
Posted: 2014-09-09
Terminated: 2014-09-30
Recalling firm: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
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.
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.
Root cause tag: design
FDA root cause: Device Design
Action: Pioneer Surgical sent a Product Field Action letter on July 7, 2013, to all affected customers. The letter described the affected product and issue, and provided instructions for return of the recalled product. All 9 affected instruments were returned to Pioneer Surgical, reconditioned and sent back to the field. Customers with questions were instructed to call 906-226-4489. For questions regarding this recall call 906-226-4812.
Quantity in commerce: 9
Distribution: Nationwide Distribution including TX, CA, IL, and FL.
Product codes and lots: Lot number: 148062, 148440

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2616-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2616-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-17	2014-09-09

Product code NKB

K130286Class IIStreamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc. / cleared 2013-04-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)