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.
Biomet 3i is recalling their product full osseotite tapered certain implant ifnt611. the depth of the implant's internal hex is too shallow. the condition, if present, may prevent the driver; cover screw or abutment from fully engaging the implant.
조치
BIOMET 3i sent an Urgent Medical Device Recall letter on March 19, 2012, to all affected customers via email or fax. The letter identified the product, the problem, and the action to be taken by the customer. Customers are to return any unopened and unused product for replacement at no cost. In addition, customers should contact Customer Service at 1-800-342-5454 for assistance if they encounter issues with the mating component, or if they have any questions or concerns. Customers are to respond to the notification regardless of whether they have product to return.
Worldwide Distribution -- United States, UK, France, Canada, Mexico, Poland, Lebanon and Hong Kong.
제품 설명
***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain. Lot #2011110798. || Intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully endentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridge work and to retain over dentures.
“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.