Events

Recall of TI TOMOFIX MEDIAL HIGH TIBIA PLATE STERILE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SYNTHES (CANADA) 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
    54437
  • Event Risk Class
    III
  • Event Initiated Date
    2013-10-18
  • 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
    A labelling correction was being initiated that affected the above reference part number and document number due to a review of the technique guide showing an identified need for additional clarification in the application notes for the tomofix medial high tibia plate technique guide.

Device

TI TOMOFIX MEDIAL HIGH TIBIA PLATE STERILE
  • Model / Serial
    Model Catalog: 440.834S (Lot serial: N/A); Model Catalog: 440.834 (Lot serial: N/A)
  • Product Description
    TOMOFIX MEDIAL HIGH TIBIA TECHNIQUE GUIDE
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

SYNTHES (CANADA) LTD.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    HC