Events

Recall of TORNIER ELBOW PROSTHESIS STEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TORNIER S.A.S..

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
    14972
  • Event Risk Class
    I
  • Event Initiated Date
    2004-02-09
  • 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
    Screw used for implantation has been detected non conform thus prevening it to completely be inserted into the spool.

Device

TORNIER ELBOW PROSTHESIS STEM
  • Model / Serial
    Model Catalog: DKY007 (Lot serial: tIGE 5920AB/VIS 6294AB); Model Catalog: DKY007 (Lot serial: TIGE 6256AB/VIS 6294AB)
  • Product Description
    ELBOW PROSTHESIS SCREW
  • Manufacturer
    TORNIER S.A.S.

Manufacturer

TORNIER S.A.S.