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
Orthodontic Wire - Product Code D ZC
원인
Heat activated niti, natural, upper, .019 x 25" arch wires mixed with size 021x0.25" arch wires.
조치
Highland Metals, Inc. notified their affected customers by e-mail and followed with an "Important Alert" letter dated July 12, 2011.
The letters informed customers of the mix up of wires. Customers were asked to contact Highland Metals at 800-368-6484 to schedule a call tag to return any remaining product. Upon receipt credit will be issued.
For additional information contact Highland Metals at (800) 448-7971 or (408) 271-2955.
Worldwide Distribution; Nationwide (USA) distribution including the states of NV, CT, and FL; and the countries of Australia and Turkey.
제품 설명
Heat Activated Niti Arches, Natural, Upper, .019x 25", Arch Wires. || Packaged in 19 packages of 100 and 6 packages of 10. || Highland Metals, Inc. || Wire used for orthodontic treatment to place in the brackets to shape teeth.