Events

Retiro De Equipo (Recall) de Device Recall Serrated Soft Tissue Shields

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 X Spine Systems 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
    68863
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2136-2014
  • Fecha de inicio del evento
    2014-07-11
  • Fecha de publicación del evento
    2014-08-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-08-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128882
  • 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
    Guide, surgical, instrument - Product Code FZX
  • Causa
    Revision b of the tissue shields of the device was 7 mm longer than the previous design.
  • Acción
    X-Spine systems contacted both customers via telephone and instructed to return the affected product back to X-Spine. All product has been recovered. The distributors have already returned the recalled product. No product was utilized in any surgical procedure. Immediate Action Taken: X-spine inventory was reviewed and two pieces of each size were recovered from finished inventory. The X-spine sales person returned the product. The distributor has returned the remaining product. The devices were recovered prior to use in any surgical procedure. For further questions please call (937) 847-8410

Device

Device Recall Serrated Soft Tissue Shields
  • Modelo / Serial
    Part numbers X079-0096 and X079-0097 with Lot #12320
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution including the states of FL and MO.
  • Descripción del producto
    Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.
  • Manufacturer
    X Spine Systems Inc

Manufacturer

X Spine Systems Inc
  • Dirección del fabricante
    X Spine Systems Inc, 452 Alexandersville Rd, Miamisburg OH 45342-3658
  • Empresa matriz del fabricante (2017)
    X-Spine Systems, Inc
  • Source
    USFDA