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.
Biomet has initiated this action following an investigation which identified that part 150367, (oss
cemented 1m stem 13x150) was incorrectly labeled as part 150368 (oss cemented 1m stem
14x150).
조치
Biomet, Inc. sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated November 1, 2011 to the one distributor with the affected product. The letter described the product, problem, and actions to be taken by the customer. The letter instructs the customer to immediately locate and remove the affected product from inventory. Additionally, the customer was asked to complete and return a Response Form via fax to 574-372-1683. Call 574-372-3983 for questions related to this notice.
OSS INTERLOK BOWED IM STEM W/SCREW 14 MM X 150 MM TI 6AL 4V ALLOY. || Hip and knee joint replacement prostheses intended for primary and revision joint arthroplasty for use in cemented applications.
“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.