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 has become aware of an increased trend in the frequency of hmrs stem fractures which occur most often between the collar and the first screw hole on the stem. the fractures occurred when the anchorage stem was used in either the distal femur proximal femur or the proximal tibia. the anchorage stem can be used in either a fixed hinge or a rotating hinge knee construct. the root cause of this issue is that the labeling on the product is inadequate to preclude inappropriate patient selection for the device design.
Model Catalog: 6367-4-013 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-012 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-011 (Lot serial: all lot/serial numbers); Model Catalog: 6365-5-019 (Lot serial: all lot/serial numbers); Model Catalog: 6365-5-017 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-112 (Lot serial: all lot/serial numbers); Model Catalog: 6365-5-015 (Lot serial: all lot/serial numbers); Model Catalog: 6365-5-014 (Lot serial: all lot/serial numbers); Model Catalog: 6365-5-013 (Lot serial: all lot/serial numbers); Model Catalog: 6365-5-012 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-115 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-114 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-113 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-111 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-014 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-015 (Lot serial: all lot/serial numbers);