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.
Zimmer inc. is initiating a removal of the cpt modular stem (item 00-8011-001-00), cpt stem petite (item 00-8011-000-05; ) and cpt femoral stem 12/14 neck taper extended offset,(item 00-8114-001-10 ) because devices were packaged in incorrect cartons and distributed internationally and domestically. zimmer received five complaints of this packaging issue.
조치
Zimmer Inc. sent an "URGENT MEDICAL DEVICE RECALL-LOT SPECIFIC" letter dated September 13, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Consignees were asked to return all recalled product with a completed Inventory Return Certification Form. Contact the firm at 1-800-348-2759 for questions regarding this notice.
Worldwide Distribution-USA (nationwide) including the states of Indiana and Oklahoma and the countries of Australia, Thailand, Malaysia, Germany, India, Bulgaria, Egypt, UK, Russian FED, Slovak, and Brazil.
제품 설명
CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10. || CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.
“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.