Safety Alert for Product name: Acetabular capsule for hip arthroplasty Registration number ANVISA: 10417940030 Hazard class: III Model affected: Acceptable MD4 Affected batches: 02243Q; 12803P; 10652Q; 10654Q.

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.

Non-deployed products should be segregated and returned to the MDT company. We recommend to users and patients that there are some technical complaints and adverse events involving the products mentioned in the Field Action (which can be verified on the Traceability Labels sent to each product), the Distributor Company and Faricante MDT and / or through the NOTIVISA System. To the users, it is confirmed that clinical follow-up of patients already implanted is not necessary, since possible failures are perceptible during the implantation procedure, making it possible to substitute the product and / or make the surgery unfeasible.