Events

Recall of CPlus

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by RTI Surgical, 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
    67093
  • Event Risk Class
    Class 2
  • Event Number
    Z-0627-2014
  • Event Initiated Date
    2013-10-07
  • Event Date Posted
    2014-01-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124694
  • 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
    Intervertebral fusion device with bone graft, cervical - Product Code ODP
  • Reason
    As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm webless c-plus implants were incorrectly documented as meeting the requirement for labeling as a partial vertebral body replacement device (vbr). while the use of this device as a partial vbr is unlikely due to the size of the device, use of this device as a partial vbr could result in a s.
  • Action
    RTI Surgical, Inc. sent an Important Notice letter dated October 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed remove fall affected product from their inventory and send back to Customers Service at 375 River Park Circle, Marquette, MI 49855 by October 16, 2013. Customers with questions were instructed to call 906-226-4489. For questions regarding this recall call 906-226-4812.

Device

CPlus
  • Model / Serial
    part numbers: 30-CW-1012-5, 30-CW-1012-6, 30-CW-1012-7, 30-CW-1012-8, 30-CW-1012-9, 30-CW-1 012-10, 30-CW-1 012-11.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution - USA including FL, MO, NY, CA, MI,and IL.
  • Product Description
    C-Plus" 10mm x 12mm Webless implants || Pioneer Surgical's C-Plus " 10mm x 12mm Webless implants are cervical intervertebral fusion devices that are intended to stabilize a cervical spinal segment to promote fusion in order to restrict motion and decrease pain. They are intended for use with supplemental fixation and autograft. These implants are manufactured from PEEK (Polyaryletheretherketone) polymer with tantalum marker pins for radiographic visualization.
  • Manufacturer
    RTI Surgical, Inc.

Manufacturer

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