U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
There was a clerical error in order entry which resulted in the recalling firm recieving spring components from a supplier made of "music wire" the recalling frim conducted tests to determine the effects of theis change in materials. the testing showed that the wire would oxidize and there would be early failure of the device.
조치
The firm send URGENT MEDICAL DEVICE RECALL NOTICES to its distributors on 7/28/2010. The notices instructed the distributors to discontinue use of the product and return it to Biomet.
“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.