Z-2573-2014Class II

Streamline CT Cervico-Thoracic System; Set Screw Ref 26-Setscrew Non-Sterile, Single Use, Rx Only

Name: Z-2573-2014 Streamline CT Cervico-Thoracic System; Set Screw Ref 26-Setscrew Non-Sterile, Single Use, Rx Only
Creator: Pioneer Surgical Technology, Inc.
Published: 2012-09-10
License: https://open.fda.gov/license/

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) / initiated 2012-09-10 / Terminated / root cause: manufacturing process

FDA source

PIONEER SURGICAL TECHNOLOGY, INC. began a recall of STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLY on 2012-09-10. FDA classified it as Class II and gives the reason as "Some set screw thread profiles were found not to be within specifications". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2573-2014
Classification: Class II
Status: Terminated
Initiated: 2012-09-10
Posted: 2014-09-03
Terminated: 2014-09-30
Recalling firm: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Product: Streamline CT Cervico-Thoracic System; Set Screw Ref 26-Setscrew Non-Sterile, Single Use, Rx Only
Product code: KWP Appliance, Fixation, Spinal Interlaminal
Reason for recall: Some set screw thread profiles were found not to be within specifications.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recall took place at the distributor/sales representative level. Communication was done through phone and email notifications on 9/10/2012. All affected set screws were to be traded out through a scheduled process. This was coordinated through Pioneer Surgical's customer service. Product was scrapped and no reconditioning took place. All affected set screws were swapped out.
Quantity in commerce: 11 sets
Distribution: Distributed in the states of NC, NH, NY, CA, MI, IL, and FL.
Product codes and lots: Lot numbers: 104875, 104876, 104877, 104878, 104879, 104880, 104881 , 117030,117031 , 121947, 124260.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2573-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2573-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-10	2014-09-03

Product code KWP

K112757Class IIPioneer Posterior Cervico Thoracic SystemPioneer Surgical Technology, Inc. / cleared 2012-03-12

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)