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.
The recalled device was manufactured with two distal pegs but package labeling indicates the device is pegless.
조치
Biomet Orthopedics sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter to all affected customers.
The letter included: reason for the recall, risks associated with use of the device, and alternate instructions for use of the recalled device. Customers are instructed to quarantine and return the devices, and a return form.
For information or questions on this recall call Biomet at (574) 371-3756.
Worldwide Distribution: (USA) Nationwide including the states of NJ, PA, LA, SD, TX, and KS; and the country of The Netherlands.
제품 설명
Vanguard PS Open Box Femoral 70 MM Left Interlock, " FOR CEMENTED USE ONLY" CO-CR-MO ALLOY. || Biomet, Inc. || A knee joint replacement prosthesis non-coated femoral indicated for cemented application only.
“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.