Events

Recall of STREAMLINE CT CERVICOTHORACIC SYSTEM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by PIONEER SURGICAL TECHNOLOGY, INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69033
  • Event Risk Class
    Class 2
  • Event Number
    Z-2573-2014
  • Event Initiated Date
    2012-09-10
  • Event Date Posted
    2014-09-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129374
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Appliance, fixation, spinal interlaminal - Product Code KWP
  • Reason
    Some set screw thread profiles were found not to be within specifications.
  • 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.

Device

STREAMLINE CT CERVICOTHORACIC SYSTEM
  • Model / Serial
    Lot numbers: 104875, 104876, 104877, 104878, 104879, 104880, 104881 , 117030,117031 , 121947, 124260.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of NC, NH, NY, CA, MI, IL, and FL.
  • Product Description
    STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW || REF 26-SETSCREW || NON-STERILE, SINGLE USE, RX ONLY
  • Manufacturer
    PIONEER SURGICAL TECHNOLOGY, INC.

Manufacturer

PIONEER SURGICAL TECHNOLOGY, INC.
  • Manufacturer Address
    PIONEER SURGICAL TECHNOLOGY, INC., 375 River Park Cir, Marquette MI 49855-1781
  • Manufacturer Parent Company (2017)
    RTI Surgical Inc
  • Source
    USFDA