Events

Recall of Streamline OCT OccipitoCervicoThoracic System, Crosslink Counter Torque Sleeve

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by RTI Surgical, Inc. (dba 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
    74031
  • Event Risk Class
    Class 2
  • Event Number
    Z-1829-2016
  • Event Initiated Date
    2016-04-22
  • Event Date Posted
    2016-05-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146011
  • 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
    Potential for a product defect where the cannula may be obstructed. this obstruction could prevent a driver from going through, which increases the potential for the driver to slip, resulting in possible patient injury.
  • Action
    RTI sent an Urgent Voluntary Product Notification dated April 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. RTI Surgical is conducting a voluntary recall of the Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve due to the potential for a product defect where the cannula may be obstructed. This obstruction could prevent a driver from going through, which increases the potential for the driver to slip resulting in possible patient injury. For further questions, please call (906) 226-4489.

Device

Streamline OCT OccipitoCervicoThoracic System, Crosslink Counter Torque Sleeve
  • Model / Serial
    Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve; Lot Number: 170684; Part Number: 26-COUNTER-T-XLINK
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US nationwide distribution in CA, FL, IN, MI, MO, NC, NY, and TX.
  • Product Description
    Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.
  • Manufacturer
    RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Manufacturer

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
  • Manufacturer Address
    RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), 375 River Park Cir, Marquette MI 49855-1781
  • Manufacturer Parent Company (2017)
    RTI Surgical Inc
  • Source
    USFDA