Events

Recall of SUPERBITE BITE REGISTRATION PASTE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by HARRY J. BOSWORTH COMPANY A DIVISION OF MYCONE DENTAL SUPPLY CO. 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
    107302
  • Event Risk Class
    II
  • Event Initiated Date
    2005-07-07
  • 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
    The impression paste accelerator one of the components hardens in its be and cannot be used to make impressions.

Device

SUPERBITE BITE REGISTRATION PASTE
  • Model / Serial
    Model Catalog: 0921815 STANDARD KIT (Lot serial: 0407-526); Model Catalog: 0921815 STANDARD KIT (Lot serial: 0407-376); Model Catalog: 0921815 STANDARD KIT (Lot serial: 0407-373); Model Catalog: 0921885 #3 (Lot serial: )
  • Product Description
    SUPERBITE BITE REGISTRATION PASTE
  • Manufacturer
    HARRY J. BOSWORTH COMPANY A DIVISION OF MYCONE DENTAL SUPPLY CO. INC

Manufacturer

HARRY J. BOSWORTH COMPANY A DIVISION OF MYCONE DENTAL SUPPLY CO. INC
  • Manufacturer Address
    SKOKIE
  • Source
    HC