Recall of MANDIBLE EXTERNAL FIXATOR SYSTEM - SCHANZ SCREW

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
    50071
  • Event Risk Class
    II
  • Event Initiated Date
    2014-10-30
  • Event Country
  • 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
    Certain components within the cmf mandible external fixator system have been labelled and/or etched with information indicating they are "mr safe". changes have been made to testing standards (astmf 2503) to designate a product safe and compatible in the mr environment. per current astm f2503 testing standards metal devices are not to be identified as mr safe.

Device

  • Model / Serial
    Model Catalog: 04.305.011 (Lot serial: ALL LOTS); Model Catalog: 04.305.010 (Lot serial: ALL LOTS); Model Catalog: 04.305.005 (Lot serial: ALL LOTS); Model Catalog: 04.305.004 (Lot serial: ALL LOTS); Model Catalog: 04.305.003 (Lot serial: ALL LOTS); Model Catalog: 03.305.105 (Lot serial: ALL LOTS); Model Catalog: 03.305.006 (Lot serial: ALL LOTS); Model Catalog: 04.305.103 (Lot serial: ALL LOTS); Model Catalog: 04.305.102 (Lot serial: ALL LOTS); Model Catalog: 04.305.101 (Lot serial: ALL LOTS); Model Catalog: 04.305.100 (Lot serial: ALL LOTS); Model Catalog: 04.305.012 (Lot serial: ALL LOTS); Model Catalog: 04.305.128 (Lot serial: ALL LOTS); Model Catalog: 04.305.134 (Lot serial: ALL LOTS); Model Catalog: 04.305.130 (Lot serial: ALL LOTS); Model Catalog: 04.305.138 (Lot serial: ALL LOTS); Model Catalog: 04.305.142 (Lot serial: ALL LOTS); Model Catalog: 04.305.140 (Lot serial: ALL LOTS)
  • Product Description
    MANDIBLE EXTERNAL FIXATOR SYSTEM - SCHANZ SCREW
  • Manufacturer

Manufacturer

  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
  • Source
    HC