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 limited number of product pouches may not have been sealed during packaging.
조치
BIOMET 3i will conduct this recall with Dentists and Health Care Professionals. Notices will be sent via a carrier with a traceable method of delivery by BIOMET 3i team members.
" All dentists and health care professionals will be notified via courier:
- Dentists and health care professionals will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their control.
- Dentists and health care professionals will return on-hand product to BIOMET 3i via a courier agency and ensure all of their products are accounted for using the form provided in the letter.
- Dentists and health care professionals will complete and return the Inventory Return Certification Form to the fax number or email address provided.
International distributors will be notified via email. Further distribution of the international customer notices will be sent through the local and regional distributors following local language translation. Communications will occur as translations are completed and are anticipated to occur during the week of September 12, 2016.1233.
Customers with questions were instructed to call the customer call center at +44 (0) 800 652-1233.
Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden
제품 설명
BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) || An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
“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.