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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There is a potential for the spring clip of the nexgen complete knee solution femoral and provisional impactor/extractor to break off during use and fall into the surgical site. zimmer has received 24 complaints of the spring clip breaking 4 of which were reported that the patient had to undergo additional x-ray to ensure the fractured clip had not been left in-vivo. there has been 1 report of the spring clip being found in-vivo during this process. these instruments (same lots) are already being recalled in relation to another issue (black coating falling off) - see recall number 62538.
“The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.