Events

Recall of HERCULITE ULTRA ENAMEL - UNIDOSE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PATTERSON DENTAL CANADA 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
    16063
  • Event Risk Class
    III
  • Event Initiated Date
    2015-02-06
  • 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
    Kerr corporation received complaints that the herculite ultra product may be difficult to extrude or may not perform as intended. the composite does not extrude easily. any composite extruded was determined to exhibit signs of dryness and was not workable upon manipulation.

Device

HERCULITE ULTRA ENAMEL - UNIDOSE
  • Model / Serial
    Model Catalog: 34348 (Lot serial: 4667889); Model Catalog: 34448 (Lot serial: 4662092); Model Catalog: 34348 (Lot serial: 4662092); Model Catalog: 34448 (Lot serial: 4678965); Model Catalog: 34348 (Lot serial: 4678965); Model Catalog: 34448 (Lot serial: 4662093); Model Catalog: 34348 (Lot serial: 4662093); Model Catalog: 34448 (Lot serial: 4734549); Model Catalog: 34348 (Lot serial: 4734549); Model Catalog: 34448 (Lot serial: 4779744); Model Catalog: 34348 (Lot serial: 4779744); Model Catalog: 34448 (Lot serial: 4791138); Model Catalog: 34348 (Lot serial: 4791138); Model Catalog: 34448 (Lot serial: 4791140); Model Catalog: 34348 (Lot serial: 4791140); Model Catalog: 34448 (Lot serial: 4786373); Model Catalog: 34348 (Lot serial: 4786373); Model Catalog: 34448 (Lot serial: 4857439); Model Catalog: 34348 (Lot serial: 4857439); Model Catalog: 34448 (Lot serial: 4861157); Model Catalog: 34348 (Lot serial: 4861157); Model Catalog: 34448 (Lot serial: 4863611); Model Catalog: 34348 (Lot serial: 4863611); Model Catal
  • Product Description
    HERCULITE ULTRA ENAMEL - UNIDOSE
  • Manufacturer
    PATTERSON DENTAL CANADA INC.

Manufacturer

PATTERSON DENTAL CANADA INC.