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.
Package labeled as sterile may have an incomplete or partial seal thereby possibly compromising sterility.
조치
Each US customer will be contacted by telephone using a prepared phone script. Following telephone contact, Biomet 3i will perform a follow-up of each call with a faxed letter. The Urgent: Medical Device Recall letter, dated 11/23/2009, identified the affected product and asked customers to return unused product for replacement. The letter also explained the clinical implications and asked customers to respond with the attached response fax and then return the abutment(s) to BIOMET 3i. Questions or concerns can be directed to Kelly Taylor at 561-776-6906.
Worldwide Distribution -- USA, Middle East, Italy, Europe, and Greece.
제품 설명
LOCATOR Restorative Abutment, ILOA002, LOT 877423, Certain LOCATOR ABUTMENT, 4.1 mm(D) X 2mm(H), STERILE Made in USA, Sterile. || BIOMET 3i 4555 Riverside Drive, Palm Beach Gardens, FL 33410 USA. || For use on tissue supported removable over-dentures on 2 to 4 implants, partially edentulous overdentures with one or more implants, limited interarch distance, angle correction with up to 40 degrees between divergent implants.
“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.