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.
Zimmer received a trend of complaints indicating corrosion of product.
조치
Zimmer issued an Urgent Medical Device Recall-Lot Specific notification via e-mail/letter dated July 19, 2014, to all affected customers. The notification identified the product the problem and the action needed to be taken by the customer.
All distributors were notified via electronic mail. Hospital risk managers and surgeons, as well as distributors with affected inventory were notified via courier. Distributors were sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the affected product in their territory as well as identifying hospitals and surgeons who have previously used the affected product. Distributors are to return on-hand affected products to Zimmer, and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers and surgeons were provided with a letter identifying the issue and their responsibilities. These responsibilities include locating the affected product, quarantining the product, and returning it to their Zimmer sales representative.
If you have questions or concerns regarding this recall please call the customer call center at 1-877-946-2761.
Worldwide Distribution - US Distribution and the countries of : Argentina, Australia, Brazil, France, Germany, India, Japan, Spain, Switzerland, and Venezuela.
제품 설명
Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number 6290-00-690. || Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter.
“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.