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.
One of the two connector ends of the medium cross connector may not be fully secured to the rod after tightening. this may not be readily apparent to the operating surgeon, resulting in inadequate torsional stability.
조치
Biomet Spine issued an Urgent Medical Device Recall letter dated September 16, 2010 to distributors and physicians, identifying the affected device and actions to be taken.
Customers and distributors were requested to identify, remove, and immediately return the affected product to Biomet, following enclosed Product Return Instructions, and complete and return the Removal Tracking and Verification Form.
Customers and distributors can contact Biomet at 1-800-526-2579.
“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.