Alerta De Seguridad para Hygiene Technical Name: Modular System for Arthroplasty Total ANVISA Registration Number: 10417940085 Hazard Class: III Model Affected: Acetabular Insert PHENOM Poly (04.13.13.xxxxx) / Acetabular Insert PHENOM Poly Rear Ceiling (04.13.14.xxxxx)

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 and / or to customers outside Brazil, they should carry out the disposal in loco as indicated by the IU 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 and the MDT Manufacturer and / or the NOTIVISA System must be reported. 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 not causing a serious adverse event to the patient.