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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The identified lot number of the bhr streamline cup introducers may mechanically seize up preventing release of the cable tightening mechanism during surgery or before use. as a result this could prolong surgery time. also if implanted this could cause a possibility of malpositioning of the cup due to use of the device in a mechanically seized condition.