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 full radius blade 3.5mm due to a manufacturing error. the product was manufactured with a black ultem sluff chamber instead of a blue polycarbonate one. smith & nephew considers that the use or exposure to the product is unlikely to cause adverse health consequences. the colour of the sluff chamber is irrelevant to the clinical use and the material has no impact on the device performance. the device will perform as intended.