Events

Alerta De Seguridad para Commercial Name: Maxillofacial Distraction System Technical Name: Bone Distrator ANVISA Registration Number: 80145901599 Hazard Class: III Affected Model: Distr. Mandib. Monoaxial Serial numbers affected: Code: 487.962 || Lot: 6164423, Quantity: 1 item and Lot: 7537258, Quantity: 5 items Code: 487.963 || Lot: 7865438 || Quantity: 10 items Code: 487.964 || Lot: 5559854, Quantity: 1 item and Lot: 5868674, Quantity: 1 item. Code: 487.965 || Lot: 5859710 || Quantity: 1 item. Code: 487.974 || Lot: 5354033, Qty: 3 items; Lot: 5860826, Qty: 1 item and Lot: 6044556, Qty: 4 items. Code: 487.975 || Lot: 6107609, Qty: 7 items; Lot: 6164420, Qty: 4 items and Lot: 5847302, Qty: 1 item.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Synthes GmbH.

¿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
    2103
  • Fecha
    2016-10-06
  • 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
    There is no DePuy Synthes replacement device available. Synthes GmbH offers a number of alternative devices that are also indicated for jaw distraction, including the Stainless Steel Mandibular Distrator System, the Titanium Multivector Distrator Module System and the Curvilinear Distraction System. Refer to the Indications and Instructions for Use for these alternative systems to determine suitability for your patients.
  • Causa
    The mandibular distrator screw can detach prematurely from the proximal base plate.
  • Acción
    Field Action Code R410682 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Company will make collection for later return to the manufacturer.

Device

Commercial Name: Maxillofacial Distraction System Technical Name: Bone Distrator ANVISA Registrat...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Synthes GmbH