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 nx3 try-in gel syringes in the affected lot contain a different product material. the material in the affected syringe does not match the shade of the cement as it is labeled. there is a risk that use of the affected material to evaluate shade prior to cementation may result in an unanticipated final restoration color requiring the need to remove and repeat the restoration.