Events

Alerta De Seguridad para Endo-Bony Solid Screw for Aesthetic Dental Implant PLUS ITI - 4.8 mm 6 mm. Article No 043.240; Lots # 1007 Maturity March 2005

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por The Straumann Co [232384], Reservoir P1 1601 Trapelo Rd, Waltham MA 02451 (distribuidor); Institut Straumann AG [281759], Hauptstrasse 26d, CH-4437 Waldenburg, Switzerland (fabricante.

¿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
    374
  • Fecha
    2002-01-16
  • 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 above dental implants may have been incorrectly labeled (named) as a wide-neck on the back of the outside of the package. the labels on the ampoule correctly identify the implant having 4.8mm of neck diameter. it is, however, possible for clinicians to believe that the implant is a wide-neck implant with a 6.5 mm diameter neck. the distributor initiated a call by letter dated 11 october 2001.
  • Acción
    Make sure you have received the Straumann USA business letter and business card dated October 11, 2001. Identify and isolate any affected product in your inventory. If you have any of the above implants in your inventory, or if you have ever used any affected product, you have to identify this product on the business card and return it to Straunmann until October 19, 2001; if you did not return the card, do so as soon as possible. Upon receipt of your card, Straumann will send materials and instructions for return pre-payment and unused (new) products that will likely be re-stocked. For more information, contact your dealer. For more information, contact the ANVISA Technovigilance Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

Endo-Bony Solid Screw for Aesthetic Dental Implant PLUS ITI - 4.8 mm 6 mm. Article No 043.240; Lo...

Manufacturer

The Straumann Co [232384], Reservoir P1 1601 Trapelo Rd, Waltham MA 02451 (distribuidor); Institu...
  • Source
    ANVSANVISA