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
Guide, surgical, instrument - Product Code FZX
원인
Product labeling of these sterile guide wires (external carton label and patient record label) states a 10-year expiration date. package testing supports a 5-year expiration date for these same guide wires.
조치
Zimmer sent an "URGENT MEDICAL DEVICE RECALL" notifications dated August 27, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Your Responsibilities:
1.Review the notification and ensure affected personnel are aware of the contents.
2.Locate part number and lot number combinations listed in attachment 1 and quarantine the devices immediately.
3.Carry out a physical count of all affected product in your territory, including hospitals in your territory with direct
sales as well as consignment, and complete the Inventory Return Certification of Acknowledgement (Attachment 2). Email a completed copy of Attachment 2 to corporatequality.postmarket@zimmerbiomet.com.
4.Return the recalled product along with the completed Attachment 2. Clearly mark the outside carton of each product return shipment made as Recall.
5.Please notify Zimmer Biomet of any hospitals and surgeons that have consumed the product in the past 12 months that are not included in either the distribution history or inventory system data information. Supply the information for
any hospitals and surgeons that you have additionally identified by using the provided spreadsheet Additional Account template. The template, and the list of known consignees from the distribution history and inventory systems data, will be emailed to you for completion and return to: corporatequality.postmarket@zimmerbiomet.com.
6.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
For further questions about this recall, please call ( 1-800-447-5633).
Worldwide Distribution - US (nationwide) including Puerto Rico and Virgin Islands., and to the countries of Canada, Brazil, Algeria, Mexico, Austria, Taiwan, Belgium, Hong Kong, Croatia, Singapore, Denmark, Bahamas, Egypt, Panama, Finland, Dominican Republic, France, Guatemala, Germany, Australia, Ireland, Japan,Italy, Haiti, Jordan, Malaysia, Kenya, India, Lebanon, Luxembourg, Malta, Mauritius, Morocco, Netherlands, Norway, Poland, Portugal, Russia, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, United Kingdom and United Arab Emirates.
“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.