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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The manuracturer has received customer complaints stating that the pulp canal sealer ewt standard product was setting too quickly. investigation has determined that the affected material does indeed set 3 hours faster than specified in the direction for use which provide a work/set time of 6 hours or greater.