Events

Notificaciones De Seguridad De Campo acerca de Optipac® 40 Refobacin® Revision and Optipac® 80 Refobacin® Revision

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Biomet Orthopedics Switzerland GmbH.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2017-12-18
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    Biomet orthopedics switzerland gmbh implements a voluntary safety corrective action regarding a medical device (withdrawal) for certain batches of optipac® refobacin® revision products (see annex 1 for a list of potentially relevant products).

Device

Optipac® 40 Refobacin® Revision and Optipac® 80 Refobacin® Revision
  • Modelo / Serial
    OPTIPAC 40 REFOBACIN REVISION 4730501163-1 A648C04670 OPTIPAC 40 REFOBACIN REVISION 4730501163-1 A648C05100 OPTIPAC 40 REFOBACIN REVISION 4730501163-1 A705B05130 OPTIPAC 40 REFOBACIN REVISION 4730501163-1 A705B06130 OPTIPAC 40 REFOBACIN REVISION 4730501163-1 A722B00240 OPTIPAC 40 REFOBACIN REVISION 4730501163-1 A722B08910 OPTIPAC 40 REFOBACIN REVISION 4730501163-1 A722B08920 OPTIPAC 80 REFOBACIN REVISION 4732501165-1 A620A01788 OPTIPAC 80 REFOBACIN REVISION 4732501165-1 A620A0178A OPTIPAC 80 REFOBACIN REVISION 4732501165-1 A705C05628 OPTIPAC 80 REFOBACIN REVISION 4732501165-1 B705B05128
  • Manufacturer
    Biomet Orthopedics Switzerland GmbH

Manufacturer

Biomet Orthopedics Switzerland GmbH
  • 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
    AMPMDRS