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
We became aware of two breakages of the pin tips. we cannot exclude a user error or that irregularities in the manufacturing process of the metal component of the product might have contributed to the described events. we decided to conduct this voluntary recall in order to ensure patient safety.