Events

Retiro De Equipo (Recall) de Device Recall Surgical bur

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 EXP Pharmaceutical Services Corp.

¿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
    Recall
  • ID del evento
    71608
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2238-2015
  • Fecha de inicio del evento
    2015-02-11
  • Fecha de publicación del evento
    2015-07-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-12-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138389
  • 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
    Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
  • Causa
    Exp did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
  • Acción
    EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014. A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.

Device

Device Recall Surgical bur
  • Modelo / Serial
    OEM Catalog number 5820-10-120.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in DC and the states of CO, CA, FL, TX, and AR.
  • Descripción del producto
    Medical Device Exchange Round Fluted Bur Soft Touch; 2.0mm; || Pouch, Tyvek/Mylar, Sterile, Single Use Only; || OEM Catalog number 5820-10-120; || EXP (repackager), Stryker (OEM) || Drills, burrs, trephines & accessories || (simple, powered)
  • Manufacturer
    EXP Pharmaceutical Services Corp

Manufacturer

EXP Pharmaceutical Services Corp
  • Dirección del fabricante
    EXP Pharmaceutical Services Corp, 48021Warm Springs Boulevard, Fremont CA 94539
  • Empresa matriz del fabricante (2017)
    Abry Partners Inc.
  • Source
    USFDA