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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During testing shaver handpiece tray failed sterrad 100s half cycle testing and did not demonstrate a sterility assurance level of 10-6 for the tps shaver. it has been determined that the reprocessing guide (p10299 rev.A) is the non-conforming part of the shaver handpiece tray and the sterilization method with inadequate sterilization validation (sterrad 100s) needs to be removed as a sterilization option for the tps small joint shaver.