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 engraving on the plastic cap does not match the outer label indications for size. the bhr acetabular cup and femoral head packages include labelling and colour coding to prevent mismatch in component size selection. the engraved numbers on the impactor cap do not agree with this information and is erroneous. as such the numbers engraved on the impactor cap could cause some confusion during surgery and lead to surgical delay.