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 medical has determined that some impression covers were manufactured with bottom cover material that did not meet their specifications. as a result some of the impression mattresses with flame barrier option do not comply with the flame-retardancy requirements as specified in the code of federal regulations.