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 instruments has become aware that the supplier of the femoral sponge part of the bioprep bone preparation system had no process or equipment validation and no documentation to support a 2 3 or 5 year shelf life.