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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Stryker was aware of a labeling issue associated with the restoration modular plasma distal stem part # 6276-5-026 lot code # 20503201 and part # 6276-5-014 lot code # 20568201. the implant [part # 6276-5-026] was discovered with two different labels on the box. the box had the correct size #26 label at one end and a different size #14 label- part # 6276-5-014 lot code 20568201 at the other end. it was determined that there was a possibility that qty 1 of the size #14 may have a size #14 label at one end and a size #26 label at the other end.