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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Conmed linvatec has determined there is a possibility that certain lot numbers of the sentinel cannulated drill bit may have the incorrect size drill bit in the package (labeled as 8 mm or labeled as 8.5 mm but may contain an 8 mm). however the correct device size is etched on the device. this recall is being conducted to the distributer and end user level.