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 determination had been made that a voluntary recall would be performed as it was reported the inserter for titanium elastic nails (ten) has the potential for mechanical failures such as breakage of the main shaft of the inserter for the ten malfunction of the chuck of the inserter for the ten in the form of the chuck getting stuck/jammed breakage of the cross bar of the inserter for the ten as a result of hammering and failure of the back end of the inserter by loosening and falling off.