This was a custom implant, there was only one (1) unit manufactured and distributed. The product has been implanted, so it is not subject to being returned.
Description du dispositif
Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. || This Rotating Hinged Knee is intended to replace patient anatomy.
“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.