Events

Recall of HELIOMOLAR CAVIFIL ASSORTMENT AND REFILLS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by IVOCLAR VIVADENT 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
    53649
  • Event Risk Class
    III
  • Event Initiated Date
    2017-07-20
  • 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
    Specific product codes and lots of heliomolar delivery form cavifil only may exhibit soft and sticky consistency and therefore may cause unexpected handling for the user during packing and contouring.

Device

HELIOMOLAR CAVIFIL ASSORTMENT AND REFILLS
  • Model / Serial
    Model Catalog: 541501AN (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 541503AN (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 541502AN (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    HELIOMOLAR REFILL (CAVIFIL)
  • Manufacturer
    IVOCLAR VIVADENT INC.

Manufacturer

IVOCLAR VIVADENT INC.