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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Smith & nephew inc. has initiated a voluntary field safety corrective action of the legion hk femoral assembly due to a manufacturing issue. the surface inside of the femoral component where cement is applied for adhesion is out of specification. the expected surface roughness is 200-325 ra. the affected devices are below allowable limits for surface roughness.