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
Staple, fixation, bone - Product Code JDR
원인
The firm is recalling togglelocs and ziploops manufactured in may and july of 2014 as they were not processed following a standard work process, which resulted in complaints of sterile packaging not being sealed.
조치
Biomet sent an Urgent Medical Device Recall Notice letter dated March 4, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediate locate and discontinued use of the product and its return to Biomet. Customers may contact Field Action Specialist, Regulatory Compliance,at (574) 372-1570.
Worldwide Distribution: US (nationwide) Distribution in the states of:TX, GA, NM, NC and OK and the countries of: Japan, and the Netherlands.
제품 설명
ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligament Fixation Device #7 PE Ziploop Extended Toggleloc || Product Usage: || The Toggleloc System is a non-resorbable system intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease.
“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.