Events

Recall of MI1000 PIN DRILL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by UNION HEARING AID CENTRE LTD.

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
    26527
  • Event Risk Class
    III
  • Event Initiated Date
    2014-03-22
  • 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
    Drills do not fit standard north american surgical drill tools. the drills provided cannot be normally used in canada. these drills were removed before distribution. this is confirmed for all but 6 units distributed which affects 2 clinics. to eliminate the remote possibilty of these drills adapted for use med-el is issuing a recall.

Device

MI1000 PIN DRILL
  • Model / Serial
    Model Catalog: 07758 (Lot serial: All); Model Catalog: 07756 (Lot serial: All)
  • Product Description
    MI1000 PIN DRILL
  • Manufacturer
    UNION HEARING AID CENTRE LTD

Manufacturer

UNION HEARING AID CENTRE LTD
  • Manufacturer Address
    TORONTO
  • Source
    HC