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.
데이터 추가 비고
knee prosthesis - Product Code JWH
원인
A knee implant labeled as left was opened and the package actually contained a right knee implant.
조치
On 4/13, 14 and 15 Biomet made phone calls to the consignees to inform them of the recall. The firm sent Urgent Medical Device Recall Notices dated 4/20/2010. The customers were instructed to immediately locate the recalled products and return them to the manufacturer.
“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.