Events

Alerta De Seguridad para All IMPLANTABLE PRODUCTS manufactured by the company. Locking System for Twister Column System - Registration: 80297610001 /// Hook for Twister column system - Registration 80297610002 /// Luminni cemented ceramic backplate - Register: 80297610003 /// Rods for column system Twister - Register: 80297610004 /// Stainless steel alloy femoral head - Registration: 80297610006 /// ET device - Registration 80297610007 - Luminni cobalt molybdenum chromium alloy femoral socket - Register: 80297610008 /// hexalobular and hexagonal Twister locking screw - Registration: 80297610013 /// PCL Cannulated Ligature Screw - Registration: 80297610015 /// PLS Solid Ligature Screw - Registration: 80297610016 /// Ancoraggi Titanium Bone Anchors - Registration 80297610017 /// Luminni Polyethylene Cement-Based Receptacle - Registration 80297610018 // / Femoral head of zirconia - Registration: 80297610019 /// Transverse locking connector - CTT - Registration: 80297610020 /// Femoral head of alumina - Regist Ro: 80297610021 /// Twister Bolts - Registration: 80297610022 /// Femoral stem of luminni chromium alloy - Registration: 80297610023 /// Titanium bone anchor Ancoraggi Eco - Registration: 80297610024 /// Cervical cage - Registration: 80297610025 // / ETD8 - Registration: 80297610026 /// Pins for garden technique - Registration: 80297610062 /// Suture screw - Registration: 80297610078 /// Lumini Cementless Rod - Register: 80297610079

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Lima Corporate Indústria e Comércio de Produtos Médicos Hosp. Ltda.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1771
  • Fecha
    2015-12-21
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Company shall collect all batches / series of related products that have not yet been implemented. /// The company was notified by ANVISA to present a plan to follow up the patients who had implanted products and a Message model to the doctors clarifying in relation to the measures to be adopted with the patients who had implanted products.
  • Causa
    It was verified during investigative inspection that the company produces its products in disagreement with good manufacturing practices.
  • Acción
    ANVISA determined the suspension of manufacture, distribution, commercialization and implantation of all the IMPLANTABLE PRODUCTS previously related, as well as determined the collection of said products available in the market.

Device

All IMPLANTABLE PRODUCTS manufactured by the company. Locking System for Twister Column System - ...

Manufacturer

Lima Corporate Indústria e Comércio de Produtos Médicos Hosp. Ltda
  • Source
    ANVSANVISA