Alerta De Seguridad para ATEC HAND SPARE PARTS. Anvisa Registration: 80047300176. Model and Affected Lot in Brazil: Model ATEC 1212-20; Lot: 805049 (5 boxes - 105 Units).

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.

The product registration holder (Medstar Importação e Exportação Ltda.) Authorized the company Pyramid Medical Systems Comércio Ltda to distribute the product in question in Brazil. In this way, users who identify products at risk in their inventories should inform the company Pyramid Medical Systems Comércio Ltda. Pyramid Ltda has already sent a statement to its customers, stating that the material ATEC 1212-20 whose batch is in reference (805049), will be collected. According to information submitted by the registry holder, no complaints or complaints have been filed by users to date. As all customers (consumers) of the product have already been communicated, the forecast for product pickup is 15 days.