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 purpose of this field safety notice is to inform affected customers of cusa tip breakage issue when using a cem nosecone models c6623 or c6636 with the cusa excel/excel+ ultrasonic aspirator and to provide an updated cem nosecone ifu with an additional warning information.