Events

Recall of ADAPTER FOR CONTRA ANGLED HANDPIECE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by INSTITUT STRAUMANN AG.

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
    141938
  • Event Risk Class
    II
  • Event Initiated Date
    2002-10-25
  • 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
    Adaapters were not heat treated during manufacture. therefore the stainless steel material did not have the necessary strength and could fail or jam when used in cases where high torque is required.

Device

ADAPTER FOR CONTRA ANGLED HANDPIECE
  • Model / Serial
    Model Catalog: 046.470 (Lot serial: 1200); Model Catalog: 046.471 (Lot serial: 1200)
  • Product Description
    ADAPTER FOR CONTRA ANGLED HANDPIECE
  • Manufacturer
    INSTITUT STRAUMANN AG

Manufacturer

INSTITUT STRAUMANN AG
  • Manufacturer Address
    BASEL
  • Source
    HC