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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Integra has become aware of incidents attribuable to the surgical technique of the panta arthodesis nail system manufactured by newdeal sas. the incidents are due to a misalignment of the calcaneal or tibial screws and the panta arthrodesis nail with or without clinical consequences during the panta arthrodesis nail surgery.
Model Catalog: 500 080 (Lot serial: All batches); Model Catalog: 500 380 (Lot serial: All batches); Model Catalog: 500 350 (Lot serial: All batches); Model Catalog: 500 280 (Lot serial: All batches); Model Catalog: 500 050 (Lot serial: All batches); Model Catalog: 500 180 (Lot serial: All batches); Model Catalog: 500 150 (Lot serial: All batches); Model Catalog: 500 250 (Lot serial: All batches)