Events

Alerta De Seguridad para SYSTEM 6 - STRYKER ENGINES FOR ORTHOPEDICS - Registro ANVISA: 80005430141. Models: 6205-000-000 / 6208-000-000 and 6207-000-000. Serial No. of Products Affected: 0819004943; 0819306143; 0821740623.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Stryker do Brasil 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
    968
  • Fecha
    2009-07-20
  • 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
    Stryker do Brasil outsources the distribution and technical assistance of this equipment to the company: BIOCAM Rua Dr. Alves do Banho, 890 Campinas - SP CEP 13030-580 Tel. 19 - 3272-3274 e-mail: biocam@biocam.com.br
  • Causa
    The equipment can continue to function even when the trigger is not depressed, potentially causing unintentional damage to soft tissue or bone.
  • Acción
    The actions recommended to the users of the product are as follows: (1) Assemble the battery, connections and drills outside the surgical field; (2) Test the trigger system before the actual intervention. The company that owns the product registration has already ordered the kits for trigger repair, and must obey the attached action schedule. There was customer visitation (see distribution list) with promotion of guidelines and labeling on handpieces.

Device

SYSTEM 6 - STRYKER ENGINES FOR ORTHOPEDICS - Registro ANVISA: 80005430141. Models: 6205-000-000 /...

Manufacturer

Stryker do Brasil Ltda.
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    ANVSANVISA