Events

Retiro De Equipo (Recall) de Device Recall JustRight 5mm Reload

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 Justright Surgical, 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
    71521
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1956-2015
  • Fecha de inicio del evento
    2015-06-11
  • Fecha de publicación del evento
    2015-07-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138064
  • 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
    Staple, implantable - Product Code GDW
  • Causa
    Justright surgical is recalling various lots of justright 5mm stapler product because they may deliver incomplete staple formation and incomplete tissue closure.
  • Acción
    JustRight Surgical sent an Urgent Medical Device Recall letter dated June 12, 2015 to aaffected customers and distributor via an email. The letter identified the affected product, problem and actions to be taken. Custers were instructed Review, complete, and return the enclosed Acknowledgement Form directly to ¿Rep¿, your Sales Representative or email to orders@justrightsurgical.com or fax to (720) 287-7135. The following assistance is available: " For questions related to the issue or product replacement, please contact your local sales representative, ¿Rep¿, or contact JustRight Surgical Customer Service at (866) 683-1743, Monday through Friday from 7:30 AM to 5:00 PM MST. " For questions related to product pick-up by JustRight Surgical, please also contact your local sales representative or Customer Service (866) 683-1743. Return instructions are provided on the Acknowledgement Form. " For questions related to the Acknowledgement Form and its return, please contact the JustRight Surgical Director of Quality Systems at (720) 287-7146.

Device

Device Recall JustRight 5mm Reload
  • Modelo / Serial
    Model Number JR-REL25-2.0 Lot numbers 75ED0114, 75JD1403, 75KD0304, 75KD0726, 75LD1224, 75AE0707, 75AE1406, 75BE1310, 75BE1313, 75CE2605, 75DE0802, and 75DE1524.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Distribution - US Nationwide and Ireland.
  • Descripción del producto
    JustRight 5mm Reload, JR-REL25-2.0 Reload is packaged in cases of 12., placed in a tray and sealed with a Tyvek lid. || Product Usage: || The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric, and thoracic surgery for the resection, transection, and creation of anastomosis.
  • Manufacturer
    Justright Surgical, LLC

Manufacturer

Justright Surgical, LLC
  • Dirección del fabricante
    Justright Surgical, LLC, 6325 Gunpark Dr, Suite G, Boulder CO 80301-3592
  • Empresa matriz del fabricante (2017)
    JustRight Surgical LLC
  • Source
    USFDA