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.
데이터 추가 비고
원인
Synthes (canada) ltd. received notification from its supplier synthes usa that a medical device recall was being initiated for the matrix threaded persuader part number 03.632.008. this recall is being initiated as synthes has become aware that during a procedure using the matrix threaded persuader the reduction insert malfunctioned which caused pieces to break off. once there is breakage to the reduction insert it will not allow the instrument to function as required. the breakage of the insert represents the potential for an un-retrieved device fragment.