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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Zimmer gmbh is initiating a recall by issuing a revised instructions for use (ifu) for the biolox option ceramic femoral head system sizes 28mm to 40mm. zimmer determined that the current information as described in the ifu and in the design rational document was confusing. the system offers the option to treat primary and revision cases. in hip revision surgery the original stem could remain in situ. for this specific scenario the biolox option ifu and the design rationale document related to the heads have been revised to improve the definition for the level of allowed damage for the stem taper.
“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.