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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Synthes (canada) ltd. received notification from its supplier synthes (usa) that a determination had been made that a voluntary recall would be performed as it was reported the affected part and lots of the pull reduction device may have been manufactured to an incorrect hardness specification which could result in intra-operative breakage.