Events

Retiro De Equipo (Recall) de Device Recall Rotating Cutter

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 Orthofix, 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
    61117
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1037-2012
  • Fecha de inicio del evento
    2012-02-06
  • Fecha de publicación del evento
    2012-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107325
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notas adicionales en la data
    surgical instrument - Product Code max
  • Causa
    The 8mm and 10mm rotating cutters may fracture during use, specifically during disc space preparation. if an 8mm or 10mm rotating cutter does fracture during use, it may result in a surgical delay estimated to be 30 minutes or greater due to preparing the disc space using other instruments or methods and/or retrieving the instrument fragment.
  • Acción
    Orthofix mailed recall letters to the distributors on 02/06/2012. Orthofix does not sell or consign these instruments to hospitals.

Device

Device Recall Rotating Cutter
  • Modelo / Serial
    Catalog Number 89-0452 (8mm Rotating Cutter) - Production Identification (Lot) Numbers 33056-ND25 and 33056-NE19; Catalog Number 89-0454 (10mm Rotating Cutter) - Production Identification (Lot) Numbers 33056-ND26 and 33056-NF02; Catalog Number 89-0030 (FORZA Discectomy Case);   UPDATED INFORMATION AS OF 04/12/2012: The firm has revised to amend the affected lot information; lot number 34346-NH30 (PN 89-0545) has been added. At the time of recall initiation 3 units from lot 34346-NH30 were in distribution; all 3 units have since been returned to Orthofix. Recall notice stated all lots are to be returned so all other information remains unchanged.
  • Clasificación del producto
    Orthopedic Devices
  • Distribución
    Nationwide and Puerto Rico
  • Descripción del producto
    Orthofix rotating cutter used in spinal fusion procedures with the FORZA Spacer System. Catalog Number 89-0452 (8mm Rotating Cutter), 89-0454 (10mm Rotating Cutter), and 89-0030 (FORZA Discectomy Case). Manual surgical instrument comprised of stainless steel and titanium.
  • Manufacturer
    Orthofix, Inc.

Manufacturer

Orthofix, Inc.
  • Dirección del fabricante
    Orthofix, Inc., 3451 Plano Pkwy, Lewisville TX 75056-9453
  • Empresa matriz del fabricante (2017)
    Orthofix International Nv
  • Source
    USFDA