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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During the manufacturing phase for certain batches of the r3 ceramic acetabular liners the titanium rings were pressed onto the ceramic component with a higher force than allowed by the manufacturing specifications. this has the potential to result in lower than expected strength for the liners.