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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Stryker has become aware that sterilization testing performed was inadequate [did not simulate worst case use situations and most challenging sites] and therefore the gravity steam sterilization duration has to be extended in the ifu.