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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Certain components within the cmf mandible external fixator system have been labelled and/or etched with information indicating they are "mr safe". changes have been made to testing standards (astmf 2503) to designate a product safe and compatible in the mr environment. per current astm f2503 testing standards metal devices are not to be identified as mr safe.
Model Catalog: 04.305.011 (Lot serial: ALL LOTS); Model Catalog: 04.305.010 (Lot serial: ALL LOTS); Model Catalog: 04.305.005 (Lot serial: ALL LOTS); Model Catalog: 04.305.004 (Lot serial: ALL LOTS); Model Catalog: 04.305.003 (Lot serial: ALL LOTS); Model Catalog: 03.305.105 (Lot serial: ALL LOTS); Model Catalog: 03.305.006 (Lot serial: ALL LOTS); Model Catalog: 04.305.103 (Lot serial: ALL LOTS); Model Catalog: 04.305.102 (Lot serial: ALL LOTS); Model Catalog: 04.305.101 (Lot serial: ALL LOTS); Model Catalog: 04.305.100 (Lot serial: ALL LOTS); Model Catalog: 04.305.012 (Lot serial: ALL LOTS); Model Catalog: 04.305.128 (Lot serial: ALL LOTS); Model Catalog: 04.305.134 (Lot serial: ALL LOTS); Model Catalog: 04.305.130 (Lot serial: ALL LOTS); Model Catalog: 04.305.138 (Lot serial: ALL LOTS); Model Catalog: 04.305.142 (Lot serial: ALL LOTS); Model Catalog: 04.305.140 (Lot serial: ALL LOTS)