Alerta De Seguridad para (1) ROD FOR HANGING TRANSMITTED DTT 100MM, Anvisa record 10208610026, lot 050231; and (2) ROD of 6.35x400MM, Anvisa record 10208610042, lot A53167-0.

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.

During sanitary inspection carried out at the company Engimplan Engenharia de Implantes Indústria e Comércio Ltda, samples of the products mentioned in this alert were collected. Such gems were submitted to tests at the Physical Metallurgy Laboratory - LAMEF with the objective of verifying the quality of the products. According to the results, the HASTE FOR HOOK DTT TRANSVERSA 100MM, lot 050231, has raw material different from that declared to Anvisa in the product registration process and HASTE Ø 6,35 X 400MM, lot A53167-0, has detected faults on the surface of the product, which compromises the use of the product. In view of these results, Anvisa ordered the suspension of the distribution, trade and implantation, throughout the national territory, of said implants.