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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This recall has been initiated because in december of 2009 lina medical issued an update to their "instructions for use" (ifu) to inform users that the loops should not be pre-tested on patients nor be used if de-shaped from their original rhomboid form. doing so can cause the loop to weaken break or cease functioning and can prolong the surgery of the patient.