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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Synthes (canada) ltd. is initiating a voluntary recall of all lots of the 3.7mm and 5.0mm dynamic locking screw (dls). the voluntary recall is being initiated following synthes' receipt of customer complaints of 3.7 and 5.0 mm dls breakages at the distal tip of the pin identified after successful healing and during planned implant removal of the whole construct. there have been no reports of permanent impairment associated with the reason for this recall to date. however synthes is aware that significant elongation of surgical time has occurred in planned implant removals which involved a broken dls screw.
Model Catalog: 09.213.022S (Lot serial: all lots); Model Catalog: 09.223.090S (Lot serial: all lots); Model Catalog: 09.223.085S (Lot serial: all lots); Model Catalog: 09.223.080S (Lot serial: all lots); Model Catalog: 09.223.075S (Lot serial: all lots); Model Catalog: 09.223.070S (Lot serial: all lots); Model Catalog: 09.223.065S (Lot serial: all lots); Model Catalog: 09.223.060S (Lot serial: all lots); Model Catalog: 09.223.058S (Lot serial: all lots); Model Catalog: 09.223.056S (Lot serial: all lots); Model Catalog: 09.223.055S (Lot serial: all lots); Model Catalog: 09.223.054S (Lot serial: all lots); Model Catalog: 09.223.052S (Lot serial: all lots); Model Catalog: 09.223.050S (Lot serial: all lots); Model Catalog: 09.223.048S (Lot serial: all lots); Model Catalog: 09.223.046S (Lot serial: all lots); Model Catalog: 09.223.044S (Lot serial: all lots); Model Catalog: 09.223.042S (Lot serial: all lots); Model Catalog: 09.223.040S (Lot serial: all lots); Model Catalog: 09.223.038S (Lot serial: all lots); Mod