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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Two different length fasteners were found to be made of stainless steel rather than the specified alloy steel. the nonconforming fasteners continue to meet the tensile safety factor requirements for the application. however given the material characteristics of stainless steel these fasteners may not be reused (re-torqued).