Events

Recall of MAXCEM ELITE REFILLS

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
    59923
  • Event Risk Class
    II
  • Event Initiated Date
    2013-05-31
  • 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
    An issue with the raw material used to produce the affected lots of maxcem elite causes the material to prematurely polymerize in the syringe.

Device

MAXCEM ELITE REFILLS
  • Model / Serial
    Model Catalog: 34418 (Lot serial: >10 CALL MANUFACTURER); Model Catalog: 33417 (Lot serial: >10 CALL MANUFACTURER); Model Catalog: 33872 (Lot serial: >10 CALL MANUFACTURER); Model Catalog: 33873 (Lot serial: >10 CALL MANUFACTURER); Model Catalog: 33874 (Lot serial: >10 CALL MANUFACTURER); Model Catalog: 33875 (Lot serial: >10 CALL MANUFACTURER); Model Catalog: 33876 (Lot serial: >10 CALL MANUFACTURER)
  • Product Description
    MAXCEM ELITE REFILLS
  • Manufacturer
    K-DENTAL INC.

Manufacturer

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