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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An anomaly has been identified whereby following prolonged use the screw fastener holding the wedge body to the tray may fail. the falling wedge presents a risk of injury to patients or other personnel in the path of the falling wedge. the risk of failure is proportional to the amount of use of the wedge and is considered significant only after many years of use. the risk is also increased for heavier wedges upper wedges used in the interface mount and for wedges where the screw fasteners are loose or have a history of becoming loose. varian is aware of this occuring only for 30 degree upper wedges. other wedges may potentially be susceptible to the same failure.