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
Conmed corporation confirmed that two lots of altrus thermal tissue fusion handpiece devices were exposed to a higher than acceptable level of particulate matter during manufacture in march 2013. device sterility and performance are unaffected by this exposure. these lots were released for distribution without following the specific documentation requirements of conmed electrosurgery to place the affected products on non-conformance report prior to disposition. in october 2013 conmed notified the usfda of their intent to recall altrus thermal tissue fusion handpieces catalog no. 60-9520-001 lot 13chb007 and 60-9522-001 lot 13chb006 due to exposure to high particle count during manufacture. only catalog no. 60-9522-001 lot 13chb006 was distributed in canada.