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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Nobel quality management systems have detected that the instructions for use (ifu) and the manual for guided surgery with nobelparallel conical connection implants include an incorrect drill protocol for the fully guided surgery using the 4.3 mm implant diameter in soft bone. the ifu and manual are related to the nobelparallel cc guided surgery kit article #38072. the instructions printed on the kit plate itself placed at the top of the plate reference the correct drills for all implant diameters and bone types.