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 has initiated a product recall of several batches of the trigen intertan nail due to a manufacturing error which resulted in the set screw being set too deep in the affected nails. during implantation when the proximal femur is being reamed to accept the lag and compression screw the reamer may impinge the set screw causing potential breakage of the reamer.