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.
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The manufacturer has determined that after a fracture of a stem neck due to scratches made by the surgeon during femoral head revision. medacta international sa has decided to modify the ifu of its hip implants adding the following sentence. "the operating surgeon has to be aware that a scratched neck can have influence to the endurance of the stem and can lead to an early fracture of the stem neck.".