Orthopedic Implants 의 안전성 경고

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
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, based on matches of data from the U.S. and Brazil.

considering the provisions of paragraph 3 of art. 111 of the Internal Regulations approved by Administrative Rule no. 593 of August 25, 2000, republished in the Official Gazette of December 22, 2000; considering the provisions of items IV of Article 10, of Law No. 6,437, of August 20, 1977; considering the provisions of Arts. 12 of Law 6,360 / 76, of September 23, 1976; considering the violation of Product Interdiction and Suspension of sales No. 11293, the Sales and Collecting Agreement of the Auto Market No. 01299, the Product Interdiction Term No. 01300 issued by the Southwest Sanitary Surveillance of the Municipality of Campinas imputed to the company Traumédica Instrumentais e Implantes Ltda, for producing and selling implantable orthopedic products without registration with ANVISA, resolves: Article 1. To determine, as a measure of sanitary interest, throughout Brazil, the prohibition and suspension of the sale of products (orthopedic implants) manufactured by Traumédica Instrumentais e Implantes Ltda. -------------------------------------------------- ------------------------------------------- ALERT UPDATE ---- ---------------------------------------------- RESOLUTION-RE N 796, dated May 18, 2004. The Director of the Collegiate Board of the National Sanitary Surveillance Agency, in the use of its attribution granted by Administrative Rule No. 149, of the Chief Executive Officer, dated February 20, 2004, considering the provisions of paragraph 3 of art. 111 of the Internal Regulations approved by Administrative Rule no. 593 of August 25, 2000, republished in the Official Gazette of December 22, 2000; considering Protocol No. 04/50/00166 PSO - VISA / SUDOESTE, published in the Official Gazette of the Municipality of Campinas / SP on February 26, 2004, which determined the manufacturing disintermediation No. 01460, of January 30, 2004, of the company Traumédica Instrumentos e Implantes - Me Ltda, resolves: Art. 1 Determine the disinterest of the company TRAUMÉDICA INSTRUMENTOS E IMPLANTES - ME LTDA, located at Rua Victorio Chinaglia, 145, Campinas / SP for the manufacture and sale of products registered with ANVISA / MS , as published in Resolution RE 691 of April 28, 2004; Art. 2 The effects of Resolution RE No. 463, of December 26, 2003, are revoked; Art. 3 This Resolution comes into force on the date of its publication