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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Possible discrepancies in the in the material drying time and consequent injection molding. parameters during the manufacture of the respective locking trigger lots. as a result of these non-conformities there is potential.For the locking trigger to fracture during usage and allow the grasper to remain in a closed position. all units/kits that were built with the suspect lots of triggers have either been put in quarantine or are included in the recall.