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 device correction (followed by a phased removal) for all serial numbers of the zimmer air dermatome ii handpieces and all lot numbers of the zimmer air dermatome ii width plates distributed between july 2012 and march 2014 (including loaner devices). this follows reports that the surface coating applied to the device is blistering peeling and discolouring after usage over time. do not return product at this time as part of this action.
Model Catalog: 00-8851-001-00 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 00-8851-202-00 (Lot serial: ALL LOT NUMBERS); Model Catalog: 00-8851-203-00 (Lot serial: ALL LOT NUMBERS); Model Catalog: 00-8851-204-00 (Lot serial: ALL LOT NUMBERS); Model Catalog: 00-8851-201-00 (Lot serial: ALL LOT NUMBERS); Model Catalog: 00-8851-215-00 (Lot serial: ALL LOT NUMBERS)
제품 설명
ZIMMER AIR DERMATOME II HANDPIECE;ZIMMER AIR DERMATOME II WIDTH PLATES
“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.