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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Synthes (canada) ltd. is initiating a voluntary recall to remove the 4.5mm curved condylar plate. this recall is being initiated as the straight condylar plate is etched with a curved condylar plate part number. the potential hazard is a possibility of a delayed surgical procedure. synthes has not received any reports of adverse events associated with the use of the 4.5mm lcp curved condylar plate subject to this notice.