Events

Recall of AEQUALIS HUMERAL RASP

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
    129380
  • Event Risk Class
    II
  • Event Initiated Date
    2013-01-30
  • 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
    Identification of a risk of rupture.

Device

AEQUALIS HUMERAL RASP
  • Model / Serial
    Model Catalog: MWA025 (Lot serial: 11E130 12A719); Model Catalog: MWA025 (Lot serial: 12A721 12A723); Model Catalog: MWA025 (Lot serial: 11B286 11B589); Model Catalog: MWA025 (Lot serial: 05B337 10B250); Model Catalog: MWA025 (Lot serial: 10C192 11A607)
  • Product Description
    Humeral broaches Aequalis 6/6.5
  • Manufacturer
    TORNIER S.A.S.

Manufacturer

TORNIER S.A.S.