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
Guide, surgical, instrument - Product Code FZX
원인
Based on a review of historic packaging validations, it was determined that a subset of product packaged at a zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. this testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failure.
조치
On 11/5/2013, Urgent Medical Device Recall Notifications were sent to affected distributors, hospital Risk Managers, and doctors informing them of the failure.
All distributors were notified via electronic mail. Hospital risk managers, surgeons and distributors with affected inventory within the expiration date of the device will also be notified via courier. The letter identifies the issue, health risks, and their responsibilities. Questions concerning the recall are directed to 1-877-946-2761
Communications outside of the United States will occur approximately two weeks after the United States communications.
Zimmer will conduct effectiveness checks in the following way:
Distributors/Hospitals/Surgeons
100% of the notifications will be tracked to ensure delivery of the notifications.
An inventory certification form will need to be returned from each distributor that certifies that all available affected product from their territory has been returned.
Additional notifications via email and FedEx will be sent to those who have not completed the required certification form or returned affected product.
Accounts will be deemed unresponsive after 3 attempts.
“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.