Events

Alerta De Seguridad para Model M / DN Intramedullary Humeral Fixation Plates. Catalog No. 00-2254-255-10; Lot # 20855000

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Zimmer Inc.

¿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
    393
  • Fecha
    2002-02-15
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The angled proximal drilling of some humerus plates above may be incorrectly oriented, making it impossible for the surgeon to guide the insertion of the screw into the target hole. the manufacturer initiated a correction by letter dated 30 october 2001.
  • Acción
    Verify that you received the letter dated October 30, 2001; operating room questionnaire; prepaid card; addressed envelope; Zimmer distribution history report. Identify and isolate any affected product in your inventory. Contact your local Zimmer representative, who will return the affected product to the Zimmer service department. With the return of the product, you will receive the free replacement and total credit. Fill out the operating room questionnaire, and mail it to Connie Morgan, Zimmer, via prepaid mail, or via fax at (1574) 372-4265. For more information, please contact your local Zimmer representative. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485. ANVISA has provided the Forms of Notifications of Occurrences on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory

Device

Model M / DN Intramedullary Humeral Fixation Plates. Catalog No. 00-2254-255-10; Lot # 20855000

Manufacturer

Zimmer Inc
  • Source
    ANVSANVISA