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.
The firm initiated this recall after becoming aware that a discovery condyle kit with hexalobula contained two male condyles instead of a male and female condyle.
조치
Biomet sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated May 25, 2011 to all affected customers. The notice describes the product, problem, and actions to be taken by the customers.
The notice instructed customers to locate and remove the product. Customers were asked to complete a response form and fax to 574-372-1683, within 3 business days. Additionally, customers were instructed to ship the package priority mail with a copy of the response form.
Questions related to this notice should be directed to 574-371-3755 or 574-371-3756, Monday through Friday 8 AM to 5 PM.
Worldwide Distribution--USA (nationwide) including the states of AR and SD and the country of Japan.
제품 설명
Condyle Kit with Hexalobular, REF 114700 DISCOVERY ELBOW SYSTEM, HUMERAL CONDYLE SET - HEXALOBULAR, CO-CR-MO / YI-GAL-4V ALLOY, IF USED FOR REVISION SURGERY, INSTRUMENTS 414926 & 414923 MAY BE REQUIRED LOT 183300, 1 SET, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE, P.O. BOX 587 WARSAW, IN 46581 USA EXPIRY DATE: 2021-03 || Elbow joint replacement prosthesis 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.