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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Through the conmed linvatec complaint handling system conmed linvatec has received complaints for "won't sense pressure" on the item numbers c7120 and c7122. the issue was confirmed through in-house testing. it was determined that an internal assembled component (molded fitting part number a41-001-007 fitting pcv barb-female) contained a scratch/grooved area on the inside diameter of the fitting that may cause the apex irrigation pump to sense a pressure drop and increase fluid flow to the surgical site.