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.
Trilogy longevity constrained liner devices were packaged in incorrect cartons. the product is packaged in the incorrect carton. product labels and patient labels are correct, matching the product inside the carton.
조치
Zimmer contacted their customer beginning the week of August 27, 2012, via telephone. Zimmer informed the customer the reason of the recall.
The customer was instructed to quarantine and return the device to Zimmer Product Service, 1777 W. Center St. Warsaw, IN 46580. The customer was asked to provide information if the product was further distributed.
For further questions please call 574-372-4316.
“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.