Events

Alerta De Seguridad para Sternalock Blu Implant Tray

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Biomet Microfixation.

¿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
  • Fecha
    2012-01-26
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120126b.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Field safety notice: biomet microfixation sternalock blu implant tray health canada has issued a type i recall concerning sternalock blu implant tray [model no.: 73-1300, 73-1301, 73-1302; lot no.: 032211, 042911, 100611, 249640, 280130, 280131, 312560, 031411, 011411], manufactured by biomet microfixation, inc. according to the report, the screw measuring area seemed inaccurate and could cause the incorrect screw to be chosen by the medical professionals. it is possible that the screw could come into contact with the lung, heart muscle, or an artery and this could result in a pneumothorax or bleeding. for details, please refer to the health canada website: http://hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/ _list/rec-ret_md-im_date_jan-mar_2012-eng.Php if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Sternalock Blu Implant Tray
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Biomet Microfixation Sternalock Blu Implant Tray
  • Manufacturer
    Biomet Microfixation

Manufacturer

Biomet Microfixation
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    DH