Events

Recall of ELEMENTS OBTURATION SYSTEM - COMBINATIONS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by K-DENTAL 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
    65959
  • Event Risk Class
    II
  • Event Initiated Date
    2018-02-20
  • 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
    A recent increase in complaints related to overheating elements. obturation units (eou). buchannan pluggers turn hot when used with the elements obturation unit.

Device

ELEMENTS OBTURATION SYSTEM - COMBINATIONS
  • Model / Serial
    Model Catalog: 973-0322 (Lot serial: All Serial Numbers)
  • Product Description
    Elements Obturation Unit Tips
  • Manufacturer
    K-DENTAL INC.

Manufacturer

K-DENTAL INC.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    K-Dental Inc
  • Source
    HC