Alerta De Seguridad para Easy-to-install dental prosthesis abument kits. Catalogs nos. (1) 61641 through 61644, (2) 62645 to 61648, (3) 61649 through 61652, (4) 61656, (5) 61657, (6) 61658; Lots nºs. (1) 320130, 320150, 320151, 320161 to 320164, 320403 to 320409, 320482, 320926, 321748, 321749; (2) 320172, 320174, 320179 to 320181, 320927 to 320931, 321750, 321752, 322079 to 322081, 322664, 322668, 322669, 322672, 333082; (3) 320182 to 320185, 321325, 321440 to 321442, 322083, 322084; (4) 321679, 326218; (5) 321680, 324398, 326342; (6) 321681; 3,595 units distributed in USA and internationally

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Nobel Biocare USA 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
    277
  • Fecha
    2002-01-25
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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 mentioned parts were sterilized and labeled "sterile" during the beginning of the manufacturing process. however, during the rework process, it is possible that some of the batches identified above have not been resterilized. the manufacturer initiated a letter correction dated july 13, 2001, to warn customers that some products from suspect lots may have been transported without resterilization. to date, 804 of the 3,595 articles have already been returned to the manufacturer.
  • Acción
    Make sure you have received the Nobel Biocare letter of July 13, 2001. Identify and isolate any affected product in your inventory. For more information, contact your local Nobel Biocare representative or directly at 1 (714) 282-4800 ext. 5073 in the USA.

Manufacturer

  • Source
    ANVSANVISA