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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It was discovered that some cork manufactured non-ha coated trident acetabular cups and some ha coated trident acetabular cups exceeded the internal validations acceptance criteria target for organic residual.
Model Catalog: 508-01-42A (Lot serial: all lot numbers); Model Catalog: 540-11-40A (Lot serial: all lot numbers); Model Catalog: 502-01-42A (Lot serial: all lot numbers); Model Catalog: 502-11-42A (Lot serial: all lot numbers); Model Catalog: 542-11-40A (Lot serial: all lot numbers); Model Catalog: 500-01-42A (Lot serial: all lot numbers); Model Catalog: 500-11-42A (Lot serial: all lot numbers); Model Catalog: 508-11-42A (Lot serial: all lot numbers)