Retiro De Equipo (Recall) de Device Recall ZeroP StarDrive Screwdriver Shaft

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 Synthes Spine.

¿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
    51781
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1348-2009
  • Fecha de inicio del evento
    2009-02-10
  • Fecha de publicación del evento
    2009-06-10
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2009-10-05
  • Fuente del evento
    USFDA
  • 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
    screwdriver instructions - Product Code ODP
  • Causa
    Tip breakage, due to inadequate instructions for use. the technique guide provided incorrect information related to use of the torque limiting attachment during screw insertion and final tightening.
  • Acción
    All affected Synthes Spine Sales Consultants were notified of the Labeling Correction via email on February 10, 2009. They were instructed to review changes with their surgeons. They were supplied with an electronic version of the corrected Technique Guide on March 11, 2009. All affected Synthes Sales Consultants and Customers were notified of this labeling change via distribution of the updated Technique Guide and a notification letter. This packet was sent via USPS certified mail on March 26, 2009. To ensure a broad and accurate distribution of notification, affected consultants and customers are defined as having been shipped Zero-P 3.0 mm Titanium Cervical Spine Locking Screws. These devices are used only with the Zero-P system.

Device

  • Modelo / Serial
    Catalog # 03.617.902 - All lots
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Distributed Nationwide and Canada.
  • Descripción del producto
    Synthes Zero-P StarDrive Screwdriver Shaft, T8, self-retaining, quick coupling, for use in spinal fusion surgery. Catalog # 03.617.902 Technique Guide.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Synthes Spine, 1302 Wrights Ln E, West Chester PA 19380-3417
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA