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.
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Definitive Castable Cylinder for Dental Restoration - Product Code NHA
원인
Biomet 3i, palm beach gardens, fl is recalling the model lpccc2 low profile abutment, non-hexed castable cylinder, lots 2010101036 and 2010101037 exp. 10/2015. package labeling may not correctly describe the package contents. product was distributed in europe only.
조치
Biomet 3i sent a "Medical Device Advisory Notice" letter dated February 17, 2011 to all affected customers.
The letter described the problem, instructed customers to returned any unused product and to confirm receipt of the notification.
For additional information, please contact Customer Service at 800-342-5454.
LPCCC2: Low Profile Abutment Non-Hexed Castable Cylinder by Biomet 3i || Castable cylinders are intended to be used to produce a definitive casting for dental restoration onto which porcelain can then be cast
“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.