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.
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Synthes (canada) ltd. received information from their supplier synthes (usa)llc that the hemostatic bone putty products were being recalled due to a potential for the material to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery.
Model Catalog: 08.901.001.97S (Lot serial: all lots); Model Catalog: 08.901.001.99S (Lot serial: all lots); Model Catalog: 08.901.001.98S (Lot serial: all lots); Model Catalog: VB1025.10S (Lot serial: all lots); Model Catalog: 08.901.001D (Lot serial: all lots)