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 (canada) was advised that anspach identified through internal sterility assurance level (sal)validation testing that several attachments failed to meet 10-6 sal when sterilized by the sterrad 100s sterilization method that is specified in the current directions for use (dfu) and operating manuals provided with the device.