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 is initiating a lot specific recall of the nexgen¿ stemmed nonaugmentable tibial component due to the devices being processed through a manufacturing cleaning operation that was operating outside of the validated parameters.
as a result, the devices may contain residual particulate from the manufacturing process.
risks include: allergic reaction due to the foreign material or late onset.
조치
Zimmer sent an Urgent Medical Device Recall letter dated September 21, 2012, to all affected customers. The letter identifiedthe product, the problem, and the action to be taken by the customer. Customers were instructed to locate and quarantine the affected product. Customers were to return the affected product along with the completed Inventory Return Certificate Form. If product was further distributed the Recall Letter should be forwarded to their customers. Product was to be returned to USA accounts - Zimmer Product Service Department, 1777 West Center St. Warsaw, IN 46580. If product has been implanted, affected surgeons will be notified. For questions regarding this recall call 574-372-4807.
Worldwide Distribution - USA including AZ,CA, FL, IA, IL, IN, MO, NE, NJ, NY, OH, PA, WA. Internationally to Thailand, Canada, Germany, France, UK, Hungary, Netherlands, Russian Fed, and Sweden,
제품 설명
NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component || The NexGen¿¿ system is a semiconstrained, nonlinked condylar knee prostheses. The device is indicated for patients with severe knee pain and disability due to rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis; collagen disorders and/or avascular necrosis of the femoral condyle; post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion, dysfunction or prior patellectomy); moderate valgus, varus or flexion deformities; salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
“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.