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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Analysis of two instruments from finished goods indicated that the press fit specifications between the dowel pin and the mating hole in the shaft were not being achieved by the supplier potentially resulting in disassociation from the instrument.