Events

Retiro De Equipo (Recall) de Device Recall Aesculap HiLine XXS handpiece

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, Inc..

¿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
    67050
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0623-2014
  • Fecha de inicio del evento
    2013-12-09
  • Fecha de publicación del evento
    2014-01-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-12-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124615
  • 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, surgical instrument, pneumatic powered - Product Code GET
  • Causa
    Certain lots of the aesculap hi line xxs handpiece (part # gb790r) were recalled due to a possible failure of the handpiece.
  • Acción
    Aesculap sent an Important Correction & Removal Notification letter dated December 9, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine all affected product and returned to AIC (USA). Customers were instructed that a Aesculap Sales Representative would contact them to schedule return of any affected inventory and replace their product. Customers were asked to complete the inventory sheet with the quantity being returned. If customers could not locate the product, they were to provide an explanation as to why the inventory would not be returned (discarded, etc.). Customers with questions were instructed to call 610-984-9414, For questions regarding this recall call 800-258-1946, ext 5067.

Device

Device Recall Aesculap HiLine XXS handpiece
  • Modelo / Serial
    Hi-Line XXS handpiece; Part Number - GB790R , Lot Number 4504385018 4504300008 4504328565 4504685847 4804685865
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including TX, NY, PA, and TN. Internationally to Austria, Switzerland, Germany, Denmark, Spain, Finland, France, Hong Kong, Israel, Italy, Japan, Netherlands, Poland, Russian Federation, and Taiwan.
  • Descripción del producto
    Aesculap Hi-Line XXS handpiece || Hi-Line XXS handpieces are used with the HiLAN¿ and microspeed motor systems to hold burrs which cut and shape bone.
  • Manufacturer
    Aesculap, Inc.

Manufacturer

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