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 and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
데이터 추가 비고
Dental Orthodontic Wire - Product Code D ZC
원인
Boxes of stainless steel orthodontic wires were mislabeled as size.018".
조치
Highland Metals sent out "Highland Metals Advisory Notice Mislabeld Products Alert" and "Advisory Notice" letters from January 11, 2008 to April 18, 2008 to all affected costumers.
The letter included: product name and affected lots. It advised them of the mislabeling and instructed them to return the product for replacement.
For additional information contact Highland Metals at (408) 271-2955
Worldwide distribution including the countries of Colombia, France, Scotland, Germany, Australia, Mexico, England, United Kingdom, Thailand; and (USA) Nationwide including the states of OK, CA, NJ, AZ, MD, LA, IL, PR, FL, NE, IN, TX, NH, NY, CO and PA.
제품 설명
Stainless Steel, Progressive Lower, .016: Arch Wires. || Intended for use in orthodontic treatment