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.
데이터 추가 비고
Screwdriver - Product Code HXX
원인
The cypher mis screw inserter may exhibit an increased rate of instrument tip failure.
조치
Biomet sent an "Urgent Medical Device Recall Notice"/Fax Back Response Form dated May 15, 2014, via Fed Ex to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to inspect their inventory for the affected product and if located to remove the product from circulation; follow instructions on the attached Fax Back Response Form prior to return of the product; and return the product using the Fed Ex label included with the notification. Customers were instructed, if if they further distributed the product, they must notify their customers of the recall via the enclosed "Dear O.R. Manger" notice. If the customers had any questions they were asked to please contact Biomet, Monday through Friday (8 am to 5 pm) at 973.299.9300 xt. 2322.
“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.