Events

Retiro De Equipo (Recall) de 6.5mm Cancellous Bone Screw

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 Encore Medical, Lp.

¿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
    63321
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0139-2013
  • Fecha de publicación del evento
    2012-10-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-01-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113489
  • 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
    Screw, fixation, bone - Product Code HWC
  • Causa
    A product complaint was received where a size 20 screw was labeled as size 30. after receipt, measurement of the screw determined it to be a size 25. further investigation also determined that there were other screws labeled as size 25, but a size 30 screw was inside of the package. it was thought that all of these screws were found in-house and were contained, but it was determined later that on.
  • Acción
    Encore Medical sent a Urgent Field Safety Notice dated September 28, 2012, to all affected customers. This notice needs to be passed on all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please contact Customer Service to place a replacement order and receive an RMA number. Return all affected devices using the RMA number. For further questions please call (512) 834-6255

Device

6.5mm Cancellous Bone Screw
  • Modelo / Serial
    Model Number 10-55-025, Lot Number 006A1057.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution only to CA.
  • Descripción del producto
    6.5mm Cancellous Bone Screw || Intended to be used for the fixation of the acetabular shell or fracture repair.
  • Manufacturer
    Encore Medical, Lp

Manufacturer

Encore Medical, Lp
  • Dirección del fabricante
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758
  • Source
    USFDA