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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This advisory notice has been issued because exactech has updated the surgical technique for implantation of the equinoxe platform shoulder system to clarify the proper technique for use of the pilot tip reamers i.E. to include a caution statement that surgeon should avoid applying a bending force to the pilot tip reamer and should avoid using the reamer to retract the humeral head as this may result in instrument breakage.