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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On april 30 2015 ndi received a complaint from a customer reporting that a drms sphere fell apart while the patient's leg was being aligned with the navigation system during a total knee replacement surgery... based on the reported complaint ndi promptly instituted a stop ship order... then performed a recall of the affected lot... further investigation has identified a similar failure mode with different root causes that has occurred at a significantly lower rate in additional lots of the product.