Events

Safety Alert for - Trade Name: Straight Bone Plate ** - Registration: 80062900001 ** - Risk Class: III - HIGH RISK ** - Validity: 21/2/2017 ** - Model: 1/3 Tubular Plate; Small A / C Card; Acetabular Reconstruction Plate; Semi-Tubular Plate; A / C board. Long; Straight A / C Plate ** - Product Presentation: * Straight Sterile Plate: Diameter 2,0mm: 22mm with 4 holes - 27mm with 5 holes - 32mm with 6 holes - 37mm with 7 holes * Straight Sterile Plate: Diameter 2, 7mm: 23mm with 2 holes - 31mm with 4 holes - 39mm with 5 holes - 47mm with 6 holes - 55mm with 7 holes - 63mm with 8 holes - 71mm with 9 holes - 79mm with 10 holes - 95mm with 12 holes * Strata Straight Plate : Diameter 4,5mm: 45mm with 3 holes - 61mm with 4 holes - 77mm with 5 holes - 93mm with 6 holes - 109mm with 7 holes - 125mm with 8 holes - 157mm with 10 holes.

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
    1337
  • 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 customers and users who have purchased the product are being informed that the product should not be used and must be returned to the manufacturer for later replacement.
  • Reason
    During research inspection carried out by entities of the national health surveillance system (snvs), it was verified that the product is not being manufactured and marketed as a sterile presentation according to its registration with anvisa. that is, the manufacture and marketing of the product is in disagreement with its registration. ## updated on 12/27/2013 - anvisa published resolution - re n ° 4,939, of december 23, 2013, determining the suspension of the disclosure, commercialization and implant, throughout the national territory, all products manufactured by the company ortobio for not complying with what determines the 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
    - Interrupt the marketing of the product in non-sterile form. * - Collection of products on the market for replacement by products in the sterile presentation. * - The collection will be informed to customers by registered letter. The alert model is attached. * - Correction of labeling and instruction of use of the product informing the presentation of the same. * - 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 (Form Follow-up Product Monitoring Form). ## 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: Straight Bone Plate ** - Registration: 80062900001 ** - Risk Class: III - HIGH RISK...

Manufacturer

ORTOBIO - IND E COM. DE PRODUTOS ORTOPEDICOS LTDA