Events

Recall of HEAT CURE ACRYLIC POWDER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MYCONE DENTAL SUPPLY CO. INC. DBA KEYSTONE INDUSTRIES.

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
    30949
  • Event Risk Class
    III
  • Event Initiated Date
    2017-12-22
  • 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
    It was discovered that the curable acrylics may not be setting properly when mixed.

Device

HEAT CURE ACRYLIC POWDER
  • Model / Serial
    Model Catalog: 1013022 (Lot serial: >10 CONTACT MFG); Model Catalog: 1013015 (Lot serial: >THAN 10 CONTACT MFR); Model Catalog: 6010048 (Lot serial: >THAN 10 CONTACT MFR); Model Catalog: 1000522 (Lot serial: >THAN 10 CONTACT MFR); Model Catalog: 1013018 (Lot serial: >THAN 10 CONTACT MFR); Model Catalog: 1013017 (Lot serial: >THAN 10 CONTACT MFR)
  • Product Description
    HEAT CURE ACRYLIC POWDER;SC MONOMER;HC MONOMER
  • Manufacturer
    MYCONE DENTAL SUPPLY CO. INC. DBA KEYSTONE INDUSTRIES

Manufacturer

MYCONE DENTAL SUPPLY CO. INC. DBA KEYSTONE INDUSTRIES