Events

Alerta De Seguridad para OSTEO BOLT TITLE ORTHOFIX; 10392060062; risk class III; Code: 99-60100 - /// Bone Screw Osteo Tite 110/40 mm Diam 6 mm Thread D 6-5 mm Lots: V1408528; V1409880. Code: 99-60103 - /// Bone Bolt Osteo Tite 180/50 mm Diam 6 mm Thread D 6-5 mm Lots: V1407155; V1409053. Code: 99-60114 - /// Bone Bolt Osteo Tite 130/40 mm Diam 6 mm Thread D 6-5 mm Lot: V1409882. Code: 99-60138 - /// Bone Screw Osteo Tite 120/30 mm Diam 6 mm Thread D 4.5-3.5 mm Lot: V1409048. Code: 99-60139 - /// Bone Bolt Osteo Tite 130/30 mm Diam 6 mm Thread D 6-5 mm Lots: V1407156; V1407169. Code: 99-60147 - /// Bone Screw Osteo Tite 160/70 mm Diam 6 mm Thread D 6-5 mm Lot: R1406979. Code: 99-60148 - /// Bone screw Osteo Tite 170/80 mm Diam 6 mm Thread D 6-5 mm Lot: R1407137.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por ORTHOFIX DO BRASIL LTDA; Orthofix Srl.

¿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
    1807
  • Fecha
    2015-12-30
  • 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
    According to the registry holder, this action is related to the labeling label of the importer, and no action is necessary for products already used and implanted in patients, because the products are in accordance with their specifications, within the standards required by the manufacturer. For the identification of the implanted materials, the label of the primary packaging is considered. Thus, the expiration date and batch considered are the same as determined by the manufacturer, therefore, this field action is not applicable.
  • Causa
    Orthofix do brasil has identified that some batches of the osteo tite orthofix bolts were suitable with divergent information on the nationalization label due to issues related to the new bar code of those products. it has been identified that after the batch number of the affected products, there is a suffix 11 and the expiration date printed is higher than the manufacturer's label, as presented in the letter to customers.
  • Acción
    Correction in Field, exchange of the nationalization label. Action code: 20150679; the company recommends checking and segregating the existing units in stock, fill in the Response Form informing your correction needs and send it to the e-mail: sac@orthofix.com.br. The company will exchange tags on customers outside the specification.

Device

OSTEO BOLT TITLE ORTHOFIX; 10392060062; risk class III; Code: 99-60100 - /// Bone Screw Osteo Tit...

Manufacturer

ORTHOFIX DO BRASIL LTDA; Orthofix Srl