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 is initiating a recall of m/dn intramedullary fixation 4.5mm diameter cortical screws listed as comp17ible with the m/dn system as it was found through review of the design history files that they are not compatible with the m/dn system. the compatibility issue can only occur at worst case print specification wherein multiple features are at maximum material condition (meaning the hole in the nail would need to be as small as possible and the outside diameter of the screw would need to be as large as possible).
Model Catalog: 00-2253-090-45 (Lot serial: ALL UNEXPIRED LOTS); Model Catalog: 00-2253-087-45 (Lot serial: ALL UNEXPIRED LOTS); Model Catalog: 00-2253-020-45 (Lot serial: ALL UNEXPIRED LOTS); Model Catalog: 00-2253-022-45 (Lot serial: ALL UNEXPIRED LOTS); Model Catalog: 00-2253-025-45 (Lot serial: ALL UNEXPIRED LOTS); Model Catalog: 00-2253-027-45 (Lot serial: ALL UNEXPIRED LOTS); Model Catalog: 00-2253-030-45 (Lot serial: ALL UNEXPIRED LOTS); Model Catalog: 00-2253-032-45 (Lot serial: ALL UNEXPIRED LOTS); Model Catalog: 00-2253-035-45 (Lot serial: ALL UNEXPIRED LOTS); Model Catalog: 00-2253-037-45 (Lot serial: ALL UNEXPIRED LOTS); Model Catalog: 00-2253-085-45 (Lot serial: ALL UNEXPIRED LOTS); Model Catalog: 00-2253-082-45 (Lot serial: ALL UNEXPIRED LOTS); Model Catalog: 00-2253-080-45 (Lot serial: ALL UNEXPIRED LOTS); Model Catalog: 00-2253-077-45 (Lot serial: ALL UNEXPIRED LOTS); Model Catalog: 00-2253-075-45 (Lot serial: ALL UNEXPIRED LOTS); Model Catalog: 00-2253-072-45 (Lot serial: ALL UNEXPIRED LOTS);
“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.