Events

Alerta De Seguridad para DHS / DCS MEDIUM INSTRUMENT Technical Name: SURGICAL INSTRUMENTS ANVISA Registration Number: 80145901733 Hazard Class: I Affected Model: Instrumental Non-Articulated No Shearing Affected Series Numbers: SKU: 338.260 || Lot: All lot numbers <8016184 SKU: 338.280 || Lot: All lot numbers <7985313

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
    2108
  • Fecha
    2016-10-27
  • 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
    We have recorded that your facility has received the product (s) subject to this recall. It is important to note that withdrawal of the product would prevent emergency surgery, so Synthes GmbH is not requiring immediate removal of the affected product (s). Synthes GmbH is in the process of developing a plan for the recovery and replacement of the indicated devices and will contact you as soon as the replacement part becomes available.
  • Causa
    There is no evidence of the biocompatibility of the material of the dhs / dcs no. 338.280 impact insert, single (part number 338.260), used in the existing product (specified lots) (polyamide 6.6 with 20% reinforcement in carbon fiber, tecamid 66 cf 20 ). synthes has not performed biocompatibility tests for this material, and there is no evidence that it has been performed by other entities.
  • Acción
    Field Action Code R2014204R 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

DHS / DCS MEDIUM INSTRUMENT Technical Name: SURGICAL INSTRUMENTS ANVISA Registration Number: 8014...

Manufacturer

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