Safety Alert for Trade name: Femoral component PL. Technical name: Femoral component for knee arthroplasty. ANVISA registration number: 80034760038. Risk class: III. Model Affected: 2630-506. Serial numbers affected :. Register: 80034760038 - Model: 2630-506 Lot: 02331S - 10 units - Date of Manufacture: 03/31/2017 .. Registration: 80034760041 - Model: 2630-306 Lot: 02539S - 10 units - Manufacture Date: 04/18 / 2017.

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 products of the aforementioned lots must be segregated and sent for company evaluation. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link