Events

Safety Alert for - Trade Name: Total Hip Prosthesis ** - Registration: 80062900002 ** - Risk Class: III - HIGH RISK ** - Validity: 21/2/2017 ** - Model: Muller Femoral Rod, Interchangeable Head C28 Cone Protek and Bipolar Head ** - Product Presentation: Sterile package containing 01 Total Hip Prosthesis composed of Bipolar Head, Interchangeable Head and Femoral Rod

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ORTOBIO - IND E COM. DE PRODUTOS ORTOPEDICOS LTDA.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1334
  • Date
    2013-11-29
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    All distributors who have purchased the product are being informed by the company that the product should not be used and should be returned to the manufacturer for testing and analysis.
  • Reason
    During investigative inspection carried out by entities of the national sanitary surveillance system (snvs), there were detected failures in processes carried out by the company in the manufacture of the product. ## updated on 12/27/2013 - anvisa published resolution - re n ° 4,939, of december 23, 2013, determining the suspension of the dissemination, commercialization and implantation, throughout the national territory, of all products manufactured by the company 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).
  • Action
    - Stop the manufacture and marketing of the product. ** - Collection of products manufactured for the analysis and testing thereof. ** - The collection is being informed to customers by email and registered letter. The alert letter template is attached. ** - 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. It will be carried out according to the own form of the company, in Annex - Product Monitoring after sale. ## 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. ##

Device

- Trade Name: Total Hip Prosthesis ** - Registration: 80062900002 ** - Risk Class: III - HIGH RIS...

Manufacturer

ORTOBIO - IND E COM. DE PRODUTOS ORTOPEDICOS LTDA