Events

Recall of PROFILE VORTEX ROTARY FILES

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DENTSPLY CANADA LTD..

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
    57221
  • Event Risk Class
    III
  • Event Initiated Date
    2016-07-07
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    As per health hazard evaluation (hhe-309) the risk is level iii as the health consequence is such that it requires or has the potential to require medical or surgical intervention. there is no long-term health impact on teh patient. also additional/unplanned internventions or corrections during the course of a treatment or after a treatment with no health risk to the patient could be experienced. the use of a larger dimension instrument can adversely affect the ability to complete endodontic treatments.

Device

PROFILE VORTEX ROTARY FILES
  • Model / Serial
    Model Catalog: PFV042021 (Lot serial: 0000116559); Model Catalog: PFV043521 (Lot serial: 0000116559); Model Catalog: PFV042021 (Lot serial: 0000117309); Model Catalog: PFV043521 (Lot serial: 0000117309)
  • Product Description
    Profile Vortex rotary files
  • Manufacturer
    DENTSPLY CANADA LTD.

Manufacturer

DENTSPLY CANADA LTD.