Events

Recall of M3 TOTAL RIGID FIXATION SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by OSTEO MEDICAL CORPORATION.

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
    108005
  • Event Risk Class
    II
  • 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
    The locking screw can fracture/break during surgical procedure.

Device

M3 TOTAL RIGID FIXATION SYSTEM
  • Model / Serial
    Model Catalog: (Lot serial: DEV LIC # 12392)
  • Product Description
    2.4 mm locking screws
  • Manufacturer
    OSTEO MEDICAL CORPORATION

Manufacturer

OSTEO MEDICAL CORPORATION
  • Manufacturer Address
    CALGARY
  • Source
    HC