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 total knee junior is rated at 45kg. ossur initiated internal test limits of 65kg or 144% rated load in 2003. the current balancing unit drawing does not have a sufficient safety margin to assure that the devices will pass the 60kg test when the component is machined tominimum material condition.