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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The affected devices were manufactured with an out of specification retainer groove location. in the event the failure occurs it would be obvious to the user in that the devices would not provide an audible indicator that the poly lock has engaged. in the event the construct is tight the user should notice the limited range of motion. however in the worst case situation if the device gives a false indicator of locking the user would not recognize the failure.