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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Synthes was notified by its supplier that within one material batch used for production of the affected parts one or several bars were mixed in with an incorrect material. specified material was 420a and material of the mixed in bar(s) was x20crmnni 12 8 6 (which is a non-magnetic austenitic steel grade used for electric generators). the wrong material results in lower than specified hardness and corrosion resistance.