Events

Safety Alert for List of Products in Annex .. SEE ALSO: 1334 ALERT; ALERT 1336; ALERT 1337.

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
    1345
  • Date
    2013-12-24
  • 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
    According to the Field Action Notification Forms, in compliance with RDC 23/2012, the company is carrying out the product of metal bone screw (Registration No. 80062900003), and for the other products referred to in the Annex, it is carrying out an action of " Monitoring after sale of product ". However, Resolution RE 4.939 / 2012 is applicable to all company products, including those covered by Alerts 1334; 1336 and 1337.
  • Reason
    During investigative inspection carried out by entities of the national sanitary surveillance system (snvs), it was identified that the company does not comply with the quality requirements established by the good manufacturing practices of medical products established by rdc 16/2013. at the time, the manufacture of all products was suspended and the company's sanitary license was temporarily canceled. in addition, anvisa has ordered the suspension of the dissemination, commercialization and implantation, throughout the national territory, of all products manufactured by ortobio indústria e comércio de produtos ortopédicos ltda.
  • Action
    The manufacture of ALL products was suspended; the products were banned at the time of inspection; the sanitary license was temporarily revoked. In addition to the measures adopted by the local VIA, ANVISA suspended the dissemination, commercialization and implantation, throughout the national territory, of all products manufactured by Ortobio Indústria e Comércio de Produtos Ortopédicos Ltda. ## 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

List of Products in Annex .. SEE ALSO: 1334 ALERT; ALERT 1336; ALERT 1337.

Manufacturer

ORTOBIO - IND E COM. DE PRODUTOS ORTOPEDICOS LTDA