Events

Retiro De Equipo (Recall) de Device Recall Custom Spine ISSYS LP Inverted Screw System

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 Custom Spine, 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
    65068
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1819-2013
  • Fecha de inicio del evento
    2013-03-28
  • Fecha de publicación del evento
    2013-07-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-10-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117828
  • 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
    Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
  • Causa
    On march 28, 2013, custom spine, inc. issued a minor removal of a lot of 18 screws that were found to be out of specification. the screw length was 5 mm shorter in length than the required specification for the screw size. the product is laser marked 8.5mm x 45mm, but its length measured 40mm.
  • Acción
    Custom Spine initiated a voluntary removal On 3/28/2013, Custom Spine initiated a voluntary removal of all 10 pieces of the ISSYS LP (8.5mm X 45mm screws) Lot 363. Distributors were contacted via phone and/or email and were asked to immediately return these parts to Custom Spine.

Device

Device Recall Custom Spine ISSYS LP Inverted Screw System
  • Modelo / Serial
    Catalog Number 048545; Lot Number L363
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including Nebraska and Virginia.
  • Descripción del producto
    Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom Spine, Inc. 9 Campus Dr. Parsippany, NJ 07054 USA. TEL: 973-808-0019 || The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine for pedicular and non-pedicular fixation.
  • Manufacturer
    Custom Spine, Inc.

Manufacturer

Custom Spine, Inc.
  • Dirección del fabricante
    Custom Spine, Inc., 1140 Parsippany Blvd Ste 201, Parsippany NJ 07054-1887
  • Empresa matriz del fabricante (2017)
    Custom Spine, Inc.
  • Source
    USFDA