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.
A complaint was received for a discolored all poly tibia. root cause analysis found that the discoloration was the result of free radical oxidation. the
oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial
light for six years prior to inert packaging and sterilization of the device.
조치
Beginning 2/25/2014 all distributors were notified via electronic mail. Hospital risk managers and distributors, surgeons with affected inventory will also be notified via courier or direct mail. The Urgent Lot Specific Recall Notice identified the issue and responsibilities. Distributors were asked to locate and remove the affected product in their territory, as well as identifying hospitals and surgeons who have previously implanted the affected product. Distributors were asked to return on-hand affected products to Zimmer and ensure all of their products are accounted for using the form provided in the letter and email it back to corporatequality.postmarket@zimmer.com.
Hospital risk managers and surgeons were asked to locate affected product and return it to their Zimmer sales representative. Questions or concerns should be addressed to customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST
Communications outside of the United States will occur approximately two weeks after the United States communications.
100 % effective checks will be done.
Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.
제품 설명
Apollo" Revision/Constrained Knee System: || SZ0-16MM AK CCK TIB INSER || SZ1-11MM AK CCK TIB INSER || SZ1-16MM AK CCK TIB INSER || SZ1-22MM AK CCK TIB INSER || SZ1-30MM AK CCK TIB INSER || SZ2-11MM AK CCK TIB INSER || SZ2-13MM AK CCK TIB INSER || SZ2-16MM AK CCK TIB INSER || SZ2-22MM AK CCK TIB INSER || SZ2-30MM AK CCK TIB INSER || SZ3-16MM AK CCK TIB INSER || SZ3-22MM AK CCK TIB INSER || SZ3-25MM AK CCK TIB INSER || SZ4-13MM AK CCK TIB INSER || SZ4-16MM AK CCK TIB INSER || SZ5-11MM AK CCK TIB INSER
“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.