Events

Retiro De Equipo (Recall) de ELAN 4 Air System

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 Aesculap Implant Systems LLC.

¿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
    79092
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0623-2018
  • Fecha de inicio del evento
    2017-09-01
  • Fecha de publicación del evento
    2018-02-15
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161326
  • 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
    Motor, drill, pneumatic - Product Code HBB
  • Causa
    The elan 4 air system was released to the market place prior to an authorized fda 510k clearance. this issue does not affected sales outside the united states (ous).
  • Acción
    On September 1, 2017 an Urgent Medical Device Recall letter was issued to customers for the ELAN 4 Air System which includes the following sub-components: ST0607 ELAN 4 Air Control Set ST0608 ELAN 4 Air Neuro Crani Set ST0609 ELAN 4 Air Spine Set ST06411 ELAN 4 Air HD Spine Set ST0614 ELAN 4 Air Micro Saw Set ST0615 ELAN 4 Air Hand Control Set ST0638 ELAN 4 Air Large Saw Set The letter directs customers to take the following actions: 1. Review the Voluntary Urgent Medical Device Recall Notification Letter in its entirety and ensure that all users in your organization and other concerned persons are informed about this recall and immediately discontinue use. 2. Determine your current inventory of affected products within your facility. Immediately remove the affected products and return to Aesculap Inc. Do not destroy any affected products. 3. Utilizing the attached Product Recall Acknowledgement Response Form on the next page of this letter, record the total number of products in your possession. If you have no inventory remaining, please enter zero (0) on the form and a REASON WHY (example, returned evaluation system to sales representative). 4. Please contact Customer Service and they will provide you with a Returned Goods number and return label. Customer Service: 1-800-282-9000 aesculap_emailorders.bbmus_service@bbraun.com

Device

ELAN 4 Air System
  • Modelo / Serial
    ELAN 4 Air System  ST0607 ELAN 4 Air Control Set  ST0608 ELAN 4 Air Neuro Crani Set  ST0609 ELAN 4 Air Spine Set  ST06411 ELAN 4 Air HD Spine Set  ST0614 ELAN 4 Air Micro Saw Set  ST0615 ELAN 4 Air Hand Control Set  ST0638 ELAN 4 Air Large Saw Set
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
  • Manufacturer
    Aesculap Implant Systems LLC

Manufacturer

Aesculap Implant Systems LLC
  • Dirección del fabricante
    Aesculap Implant Systems LLC, 3773 Corporate Pkwy, Center Valley PA 18034-8217
  • Empresa matriz del fabricante (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA