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 is initiating a voluntary field corrective action/recall of various batches of the rci screw due to a carton label error. the carton label incorrectly identifies the screw as a "reverse thread" screw. the screw presented in the package is a standard thread screw which is correctly identified on the inner pouch label. in the event the screw is presented for use the user would notice that the device is not a reverse thread screw. the user would replace the screw or use the provided screw to complete the procedure using a clockwise rotation.