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.
A potential commingle that could result in the product in the package not matching the product on the outer label.
조치
On March 7, 2018 Field Safety Corrective Action Notices were hand delivered by Zimmer Biomet team members or their representatives. Customers were instructed to complete the following:
1.Review this notification for awareness of the contents.
2.Assist your Zimmer Biomet sales representative to quarantine immediately all affected implants.
3.Your Zimmer Biomet sales representative will remove the affected implants from your facility.
4.Complete Attachment 1 Certificate of Acknowledgement.
a. Return a digital copy to fieldaction.emea@zimmerbiomet.com.
b. Retain a copy of the Certificate of Acknowledgement with your field action records in the event of a compliance audit of your documentation.
5.If after reviewing the notice you have further questions or concerns please contact your Zimmer Biomet representative.
There was no distribution to the US. The distribution occurred to the following countries: Belgium, Switzerland, Germany, France, Canary Islands, Italy, and Thailand.
“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.