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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The recall has been initiated due to an issue with the device breaking during surgical procedures where the sternum needs to be retracted. the device is breaking where the retractor blade assembles to the stainless steel retractor body. the device is not breaking where it comes in contact with the patient. use of this device may cause a risk to the patient and hospital staff if the device breaks at the retractor blade and retractor body connection point this could prolong the surgery.