Events

Retiro De Equipo (Recall) de Device Recall Extremity Medical Disposable Instrument 1.6 mm Guidewire

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 Extremity Medical LLC.

¿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
    64330
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0952-2013
  • Fecha de inicio del evento
    2013-01-10
  • Fecha de publicación del evento
    2013-03-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115841
  • 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
    Passer, wire, orthopedic - Product Code HXI
  • Causa
    The 1.6 mm guidewire is undersized up to 2 mm in length. when used with the depth gauge, the measurement reading will not correspond with the desired screw length. the selected screw size based on the depth gauge reading will be about 2 mm longer than intended.
  • Acción
    Extremity Medical sent an "URGENT: FIELD SAFETY NOTICE" dated January 10, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Response Form was included for customers to complete and return. Contact Customer Service at 1 (973) 588-8980 for questions regarding this notice. On April 10, 2013, Extremity sent notifications to their customers at the surgeon level. They were asked to complete the attached product field action response form.

Device

Device Recall Extremity Medical Disposable Instrument 1.6 mm Guidewire
  • Modelo / Serial
    Catalog Number 101-00006; Lot Number 00921538.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA including the states of Florida, Pennsylvania, New Hampshire, Oklahoma, California, Maryland, Arizona, Ohio, North Carolina, Texas, Virginia, Illinois, New York and Tennessee, and the countries of Australia, Belgium, Israel, Netherlands and United Kingdom.
  • Descripción del producto
    Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained in Extremity Medical Surgical Kits including CompressX, Hallu.X, IO Fix and XMCP. Used in the selection of screw size when used with appropriate depth gauge.
  • Manufacturer
    Extremity Medical LLC

Manufacturer

Extremity Medical LLC
  • Dirección del fabricante
    Extremity Medical LLC, 300 Interpace Pkwy Ste 410A, Parsippany NJ 07054-1148
  • Empresa matriz del fabricante (2017)
    Extremity Medical Llc
  • Source
    USFDA