Alerta De Seguridad para - Trade Name: Ortobio Knee Arthroscopy Prosthesis ** - Registration: 80062900004 ** - Risk Class: III - HIGH RISK ** - Validity: 24/4/2017 ** - Model: Femoral Component, Patellar Component and Tibial Base Component and Tibial Plateau ** - Product Presentation: Individual sterile packaging containing = 54mm, 59mm, 64mm, 69mm, 72mm Patellar component: 26mm, 28mm, 30mm, 32mm, 34mm, 36mm, 38mm, 40mm; * = Tibial component: 54mm, 59mm, 65mm, 69mm, 72mm lateral measurement ìmedial and 8mm, 10mm, 12mm, 15mm, 18mm, 21mm, 25mm thick

Safety alert

1336

2013-11-29

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

During investigation inspection carried out by entities of the national system of sanitary surveillance (snvs), failures were detected in the processes carried out by the company in the manufacture of the product. ## updated on 12/27/2013 - anvisa published resolution - re n ° 4,939, de december 23, 2013, determining the suspension of the dissemination, commercialization and implantation, throughout the national territory, of all products manufactured by ortobio for failing to comply with resolution 16/2013 of good manufacturing practices of medical products. (annex resolution - re no. 4,939, of december 23, 2013, published in official gazette no. 249, dated 12/24/2013, section i, page 74).

- Issue of alert message with the purpose of informing about the possibility of incompatibility between implant and instruments. The alert message will be sent as attachment - Alert Message. ** - Monitor the behavior of the product in the market (products already implanted) by means of contact with the clients and doctors for whom the product was commercialized. The monitoring will be carried out according to the annex - Post sale monitoring. ## UPDATED ON 05/20/201 - Publication of RESOLUTION - RE N ° 1,882, dated 05/16/2014, in DOU Nº 93 - Section 1, dated 05/19/2014, page 49, which partially revoked Resolution- RE nº 4.939, of December 23, 2013, releasing, throughout the national territory, the disclosure, commercialization and implantation of all the products listed in the table below, manufactured as of the publication date of this Resolution RE: . Orthoped Blocked Intramedullary Stem System - 80062900010; (ii). Blocking Screw for Intramedullary Rod - 80062900015; (iii). Titanium Threaded Anchor - 80062900011; (iv). Interference Bolt Romba Thread in Titanium -80062900017; (v). Sponge Bolt in Stainless Steel - 80062900018; (saw). Transverse Interference Screw - 80062900020; (vii). Special plates without rigid fixation for large and small fragments - 80062900014; (viii). Special plates blocked LPS in steel for large and small fragments - 80062900021. It should be noted that THE SUSPENSION OF THE DISCLOSURE, MARKETING AND IMPLANTS OF THE OTHER PRODUCTS MANUFACTURED BY THE COMPANY REMAINS IN FORCE. ##