Events

Retiro De Equipo (Recall) de Device Recall Medline Anterior Cervical Distraction Pin

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 MEDLINE INDUSTRIES 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
    76298
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2106-2017
  • Fecha de inicio del evento
    2016-12-14
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152774
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Causa
    Product's non-conformity involves the integrity of the seal in the sterile packaging. it is possible that the seal on the sterile packaging has been compromised resulting in a loss of sterility of the medical device contained within.
  • Acción
    Medline Industries sent an Immediate Action Required letter dated December 14, 2016, to all affected customers with response forms via US mail, notifying them of the recall. Customers were instructed to quarantine affected product and return it to the firm. The product will be repackaged and sterilized. Customers with questions were instructed to call 866-359-1704. For questions regarding this recall call 847-643-3245.

Device

Device Recall Medline Anterior Cervical Distraction Pin
  • Modelo / Serial
    Item# MDS9091414A; Lots #136190
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA || Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.
  • Manufacturer
    MEDLINE INDUSTRIES INC

Manufacturer

MEDLINE INDUSTRIES INC
  • Dirección del fabricante
    MEDLINE INDUSTRIES INC, 3 Lakes Dr, Northfield IL 60093-2753
  • Empresa matriz del fabricante (2017)
    Medline Industries Inc.
  • Source
    USFDA