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
prosthesis, knee - Product Code NRA
원인
Packages labeled as "right" actually contain a "left" component.
조치
Biomet salesmen were notified by phone and instructed to retrieve the products. One customer was notified by letter dated 12/19/08 that use of the product should cease and that a salesman would pick up the product. A second customer had implanted the product and was hand delivered a letter dated 12/19/08 instructing that the patient should be monitored and symptoms treated as necessary. Contact Biomet at 574-362-3983 for assistance.
Biomet Oxford Unicompartmental Knee, Phase 3, Right Medical Tibial Tray, Standard Size B, CoCr, sterile, Biomet UK Ltd, Bridgend, UK; . || Unicompartmental knee joint replacement system. Designed to allow for motion between the plastic tibial bearing and metal tibial baseplate components of a unicompartmental knee prosthesis.
“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.