Events

Alerta De Seguridad para Implantable Spinal Fusion Stimulators

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

¿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
    2017-05-31
  • Fecha de publicación del evento
    2017-05-31
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170531.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
    Medical device safety alert: zimmer biomet implantable spinal fusion stimulators the united states food and drug administration (fda) has issued a medical device safety alert concerning spf plus-mini (60μa/w) & spf spf xl iib implantable spinal fusion stimulators, manufactured by zimmer biomet. the affected devices are identified as follows: serial numbers: spf-xl iib: 224595, 224598, 224607, 224608, 224610, 224613, 224615, 224621, 224622, 224623, 224624, 224625, 224626, 224644, 224649, 224651, 224655, 224656, 224658, 224659, 224666, 224667 spf-plus: 410093, 410094, 410096, 410103, 410111, 410115, 410119, 410148, 410151, 410158, 410171 distribution dates: 28 march 2017 to 6 april 2017 manufacturing dates: 11 october 2016 to 18 january 2017 the manufacturer is recalling the spf plus-mini and spf xl iib implantable spinal fusion stimulators due to higher than allowed levels of potential harmful chemicals, which may be toxic to tissues and organs (cytotoxicity) and that were found during the company's routine monitoring procedure. a cytotoxicity test is a part of the biological evaluation of medical devices to ensure compatibility with the device and the human body. a positive cytotoxicity test (failed result) can indicate that a device contains potential harmful chemicals at amounts or levels that could be dangerous to the patient. the use of affected product may cause serious adverse health consequences, including but not limited to chronic infections, long-term hospitalization due to additional surgical procedures, paralysis, and death. on 20 april 2017, the manufacturer sent an urgent medical device removal notification to all affected users. the notice instructed affected users to: quarantine all affected products. surgeons are reminded that normal clinical monitoring is recommended for 3-6 months post operatively for any patient with the affected devices implanted. product removal is on-going. according to the local supplier, the affected products are not distributed in hong kong. for details, please refer to the fda websites: https://www.Accessdata.Fda.Gov/scripts/ires/index.Cfm#event_77089 https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm561044.Htm https://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm561004.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 31 may 2017.

Device

Implantable Spinal Fusion Stimulators
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Zimmer Biomet Implantable Spinal Fusion Stimulators
  • Manufacturer
    Zimmer Biomet

Manufacturer

Zimmer Biomet
  • 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