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
Template - Product Code HWT
원인
Mislabeled - device packages labeled as hooded trial inserts contain standard trial inserts.
조치
Zimmer contacted the two affected accounts directly by phone on November 15, 2010 to inform them of the recall. Zimmer will monitor the return of the affected instruments and account for the outstanding instruments until the removal action is complete. Each of the affected accounts will be provided with a new trial insert, manufactured and packaged with the correct component. The accounts will be asked to return the affected units back to Zimmer where the returned product will be destroyed.
Customers can contact Zimmer at 574 371-8852 concerning this recall.
“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.