Events

Alerte De Sécurité sur - 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.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par ORTOBIO - IND E COM. DE PRODUTOS ORTOPEDICOS LTDA.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1337
  • Date
    2013-11-29
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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