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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Smith & nephew inc. has initiated a field correction of various lots of the trigen internal hexrecon screw due to a packaging error. based on internal evaluation various lots of the screws were distributed with an incorrect ifu. the fracture fixation ifu was packaged with the device instead of the correct ifu intramedullary nail system.