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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Ethicon inc. is initiating a recall for two product codes of proceed surgical mesh distributed in canada. the possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination.