Events

Alerta De Seguridad para Titanium Bone Anchor Drivers: (1) With Integrated Nylon Sutures, (2) With Integrated Polypropylene Sutures; Fixers for AxyaLoop 5mm Titanium Bone Screws from the following sets of Shoulder Rotation Tendon Correction Procedures: (3) Arthroscopic, (4) Mini-Open. We. Catalog: (1) 1227; (2) 1221; (3) 1502-3, 1506-3; (4) 1501-3; Lots Nos .: (1) 201990, 201991; (2) 201827, 202049; (3) 202052, 202067, 202138, 202193; (4) 202051, 202066, 202183, 202192

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Axya Medical 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
    688
  • Fecha
    2003-03-07
  • 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 rods of the above mentioned fasteners can break and do not fit with the fastener head (anchors). the manufacturer initiated a correction / recall by letter dated october 24, 2002.
  • Acción
    Make sure you received the letter from Axya Medical on October 24, 2002. Identify and isolate any affected product in your inventory. For further information, please contact your local Axya representative. ANVISA has provided the Occurrence Notification Forms on the Internet http://www.anvisa.gov.br/sistec/notificacaoavulsa/notificacaoavulsa1.asp so that you notify if there are any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

Titanium Bone Anchor Drivers: (1) With Integrated Nylon Sutures, (2) With Integrated Polypropylen...

Manufacturer

Axya Medical Inc
  • Source
    ANVSANVISA