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 voluntary recall of 64 lots (752 implants total) of m/l taper with kinectiv¿ femoral stems and modular necks due higher than allowed cytotoxicity levels found with the product. reasonable probability of adverse biological response and subsequent revision.
조치
Zimmer, Inc. sent an URGENT MEDICAL DEVICE RECALL letter dated May 18, 2015, to all affected consignees. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were instructed to review the notification and ensure affected personnel are aware of the contents. Locate all affected product identified and quarantine them immediately. Carry out a physical count of all affected product in their inventory and complete the Inventory Return Certification Form. Email a completed copy to corporatequality.postmarket@zimmer.com. Return the recalled product along with the completed Inventory return Certification Form. Notify Zimmer of any hospitals that they have further distributed the affected product to. In addition, identify the surgeons that have implanted the product. Supply the information for any hospitals that they have identified, as well as the affected surgeons using the provided spreadsheet template. Customers with questions or concerns should call the customer call center at 1-877-946-2761.
Worldwide Distribution - US Nationwide in the states of AK, AL, AZ, CA, FL, GA, IL, IN, KS, MA, MI, MN, MO, NC, NY, OH, OK, PA, TX, UT, VA, WA, WI and countries of Canada, Australia, Japan, Taiwan, France, Germany, Spain, and Italy.
제품 설명
M/L Taper with Kinectiv¿ Technology. || prosthesis, hip, semi-constrained (metal uncemented acetabular component) || Product Usage: Usage: || Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.
“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.