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 is being initiated due to the supplier reporting the possibility exists for intraoperative reamer head breakages which could also allow for un-retrieved fragments of non-implant grade material.
Model Catalog: 352.085 (Lot serial: 15932 through 19396); Model Catalog: 352.085 (Lot serial: 20141 through 24510); Model Catalog: 352.085 (Lot serial: 1448284 through 2087630); Model Catalog: 352.085 (Lot serial: 24613 through 25347); Model Catalog: 352.085 (Lot serial: 4399543 through 5870257)