Events

Recall of 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
    129484
  • Event Risk Class
    II
  • Event Initiated Date
    2014-04-14
  • 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
    Labelling changes have been made to synthes external fixation systems (small medium and large) related to magnetic resonance (mr) conditions as a result of changes in required testing protocols/standard to designate a product mr safe mr conditional and mr unsafe. metal devices are no longer identified as mr safe and as a result synthes external fixation systems are no longer labelled mr safe. the synthes external fixation systems are now identified as mr conditional.

Device

SCHANZ SCREW
  • Model / Serial
    Model Catalog: 294.55 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.783 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.782 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.779 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.774 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.773 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.772 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.771 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.778 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.777 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.776 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.775 (Lot serial: >10 numbers contact mfg); Model Catalog: 294.775SHA (Lot serial: >10 numbers contact mfg); Model Catalog: 294.776SHA (Lot serial: >10 numbers contact mfg); Model Catalog: 294.777SHA (Lot serial: >10 numbers contact mfg); Model Catalog: 294.779SHA (Lot serial: >10 numbers contact mfg); Model Catalog: 294.7
  • Product Description
    SCHANZ SCREW
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

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