5950 with specific lots distributed between February 26, 2010 and May 15, 2014
Product Description
This device is indicated for patients with severe knee pain and disability due to: • rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. • Deogenous disorders, and / or vascular necrosis of the femoral condyle. • Post-traumatic loss of joint configuration, particularly when there is a patellofemoral erosion, dysfunction or previous patellectomy. • Moderate deformitiesvalue, varus or flexion. • The rescue of unsuccessful surgical attempts previously or for knee in which satisfactory stability can be obtained at the time of surgery.
“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.
5980 and 5986, lots 62491580 and 62460315 respectively
Product Description
This device is indicated for patients with severe knee pain and disability due to: • rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. • Deogenous disorders, and / or vascular necrosis of the femoral condyle. • Post-traumatic loss of joint configuration, particularly when there is a patellofemoral erosion, dysfunction or previous patellectomy. • Moderate deformitiesvalue, varus or flexion. • The rescue of unsuccessful surgical attempts previously or for a knee in which satisfactory stability can not be obtained at the moment of surgery.