Retiro De Equipo (Recall) de Device Recall Farabeuf Clamp for 3.5mm Screws PRO

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Stryker GmbH.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Estado del evento
    Open, Classified
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Clamp - Product Code HXD
  • Causa
    Laser etching which indicates whether the device is in compression or distraction mode appears to be on the wrong side of the lever arm.
  • Acción
    On May 8, 2018, URGENT PRODUCT RECALL and BUSINESS REPLY notices were issued to U.S.A customers via UPS. Customers are encouraged to take the following actions: 1. Inform individuals within your organization who need to be aware of this device recall. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. Response is required by submitted the completed response form via email to:, even though you may not have any physical inventory on site anymore. 3. Quarantine and discontinue use of the recalled devices. 4. Maintain awareness of this notice internally until all required actions have been completed within your facility 5. Inform Stryker if any of the subject devices have been distributed to other organizations. a) Please provide contact details so that Stryker can inform the recipients appropriately. b) If you are a Distributor, note that you are responsible for notifying your affected customers. Customers with questions may call 201-831-5000.


  • Modelo / Serial
    Lot # 04857V
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    AR, CA, ID, IL, MD, MI, NJ, NY, OK, SD & TX
  • Descripción del producto
    Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463
  • Manufacturer


  • Dirección del fabricante
    Stryker GmbH, Bohnackerweg 1, Selzach Switzerland
  • Empresa matriz del fabricante (2017)
  • Source