Events

Recall of COMPOGLASS F CAVIFIL

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
    53499
  • Event Risk Class
    III
  • Event Initiated Date
    2014-02-11
  • 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
    Based on customer complaints that the material was not fully polymerizing an analysis of the retained sample confirmed that batch s09397 does not meet the specification in terms of curing depth. (specification >>=2.0mm test result 1.74mm). a chemical analysis showed that the amine initiator (ethyl p-dimethylamino benzoate) was not present in the material (expected 0.4% result <0.002%). the other initiator used in the material campherquinone was present in the material. the lack of amine initiator could result in the material curing inadequately.

Device

COMPOGLASS F CAVIFIL
  • Model / Serial
    Model Catalog: 546980AN (Lot serial: S09397)
  • Product Description
    Compoglass F Cavifil
  • Manufacturer
    IVOCLAR VIVADENT INC.

Manufacturer

IVOCLAR VIVADENT INC.