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
Driver, surgical, pin - Product Code GFC
원인
The persona 48mm x 2.5mm female screw is being recalled due to potential use of the screw in cortical bone, and corresponding stripping of the 2.5mm persona hex driver.
조치
Zimmer sent an URGENT MEDICAL DEVICE RECALL notifications dated September 9, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
1. Review the notification and the updated portion of the Persona surgical technique provided in Attachment 1, and ensure affected personnel are aware of the contents.
2. Locate and quarantine any affected product listed above and notify your Zimmer sales representative.
3. Your Zimmer sales representative will remove the recalled product from your facility.
4. If after reviewing this notification you have further questions or concerns please call the customer call center at
1-877-946-2761 between 8:00 am and 5:00pm EST.
Nationwide Distribution including the states of : HI, CA, UT, NY, OH, IN, AL, FL, GA, WI, IA, MN, NE, SD, NJ, PA, ND, IL, MO, VA, MD, NC, MI, OR, WA, KS, KY, TN, WV, OK, CT, MA, ME, AZ, NM, TX, LA, ID, CO, MT, UT, NV and AK., and Internationally to Singapore, Japan, Germany and Canada.
제품 설명
Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2. Sterilized using irradiation, single use.
“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.