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 inner diameter of the bur guards may be out of specification. it was discovered that the injection molding tool was leaving additional material on the inner surface of the bur guard that is closest to the rotating nose of the impaction drill.