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

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 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.


  • Modelo / Serial
    Model Number JR-ST25-2.0 Lot numbers 75ED0116, 75JD1404, 75KD0308, 75KD1216, 75LD0508, 75AE0709, 75AE2601, 75BE0506, 75BE2315, 75CE1630, 75CE2606, 75DE0102, and 75DE0804 (UK distribution).
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Distribution - US Nationwide and Ireland.
  • Descripción del producto
    JustRight 5mm Stapler, JR-ST25-2.0 Stapler is packaged in cases of 6, 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


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