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 is initiating a labelling recall related to the synthes 6.5mm midfoot fusion bolt technique guide. the need was identified for additional clarification in the 6.5mm midfoot fusion bolt technique guide to reduce the potential for bolt back-out or migration by emphasizing the need for supplemental fixation.