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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Fissured or broken weld seams continue to be reported from the field for hlx 2004-5 df hlx 3004-5df and xten df. the spring arms that are still in use are now more than 10 years old. this new field action is launched to replace all remaining spring arms in combination with hlx 2004-5 df hlx 3004-5 df and xten df.
Model Catalog: ARD567910910 (Lot serial: up to SN 44060038859); Model Catalog: ARD567910901 (Lot serial: up to SN 35060032600); Model Catalog: ARD569002999 (Lot serial: up to SN 4306038616); Model Catalog: ARD567801093 (Lot serial: up to SN 36060033055); Model Catalog: ARD567801094 (Lot serial: up to SN 45060039322)