Events

Recall of TELIO CS C & B STARTER PACK

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
    26448
  • Event Risk Class
    III
  • Event Initiated Date
    2016-07-01
  • 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 2 customer complaints that the material was wearing faster than expected the manufacturing process is suspected to be the cause of the issue. after a few seconds of polishing with moderate force parts of the cups are breaking away.

Device

TELIO CS C & B STARTER PACK
  • Model / Serial
    Model Catalog: 628244AN (Lot serial: V19582); Model Catalog: 634464 (Lot serial: VL0705); Model Catalog: 634459 (Lot serial: VL0843)
  • Product Description
    TELIO CS C & B STARTER PACK;OPTRAPOL NG ASSORTMENT;OPTRAPOL NG REFILLS
  • Manufacturer
    IVOCLAR VIVADENT INC.

Manufacturer

IVOCLAR VIVADENT INC.