Retiro De Equipo (Recall) de Device Recall Integra CUSA Excel Sterile Torque Wrench (23 kHz)

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 Integra LifeSciences Corp..

¿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
    Instrument, ultrasonic surgical - Product Code LFL
  • Causa
    Some 23 khz torque wrenches were incorrectly assembled and contained a 36 khz hex wrench insert instead of the 23 khz hex wrench insert.
  • Acción
    Integra sent an Urgent: Voluntary Medical Device Recall letter dated March 10, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The written notifications were delivered to US consignees by traceable courier service and non-US consignees by traceable email or facsimile. Integra is asking that you do the following: 1. Review your unused inventory of 23 kHz CUSA Sterile Torque Wrenches and determine if they are on the affected lot number list on the next page and if they are still in the box. 2. Complete the attached form. - If you do not have an affected lot number on the list (see page 2), YOU CAN CONTINUE TO USE THE WRENCHES. Check the box I do not have any affected products on the list - If you do have product(s) on the affected lot number list, AND THEY ARE STILL IN THE BOX, determine if the box also has a green dot sticker as in the photo below. If so, YOU CAN CONTINUE TO USE THE WRENCHES. Check the box I do not have any affected products on the list on page 2. 3. Complete the other information on the form if you do or do not have affected products, return the form by email or fax as indicated on the form. Keep a copy of the form for your records. When your form is received, if you have noted you have affected products Customer Service will contact you and provide an RMA number and directions to return the product, as well as input an order to replace the quantity you indicated on the form. Should you have any questions regarding these instructions, please contact Customer Service at 1-855-532-1723. We apologize for any inconvenience this may cause and thank you for your cooperation in this effort.


  • Modelo / Serial
    Product/Catalog Number C5601; Lot Numbers 1132424, 1132883, 1132884, 1133453, 1133454, 1133455, 1134067, 1134675, 1134873 and 1135014
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA (nationwide) including the countries of Australia, Canada, and Switzerland.
  • Descripción del producto
    Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+ System ultrasonic surgical instrument. The torque wrench is used to properly secure the CUSA tip to the CUSA handpiece in the sterile field.
  • Manufacturer