Events

Retiro De Equipo (Recall) de Device Recall Tibiaxys Ankle Arthrodesis Plate Compression Guide

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
    Recall
  • ID del evento
    61041
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1144-2012
  • Fecha de inicio del evento
    2011-11-17
  • Fecha de publicación del evento
    2012-03-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107319
  • 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
    Ankle arthroplasty implantation system - Product Code OYK
  • Causa
    During 6/30/2010 to 8/17/2011 the firm received five (5) incident complaints of breakage of the threaded part of the compression guide which potentially occurred when: 1) a compression is applied between talus and tibia. (step 3 of the product description) or when 2) the surgeon screws the compression guide into the plate which most likely was attributed to improper surgical techniques used durin.
  • Acción
    Integra sent a "Field Safety Notice" letter dated November 17, 2011 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review the Surgical Techinique Manual and follow the recommended guiidelines to avoid breakage. ensure that this information is distributed to their surgical teams, and fill out the enclosed "Field Safety Notice Acknowledgement and Return Form" and return to bonnie.kuzbyt@integralife.com or fax to 1-609-750-7999. For questions call 609-936-6932 or email at sean.luland@integralife.com.

Device

Device Recall Tibiaxys Ankle Arthrodesis Plate Compression Guide
  • Modelo / Serial
    Model #159635, part # 159 635, Batch #: EAHZ, EAJ1, ELGV, ENQE & ENQH.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including the states of; AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MO, MN, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA & WI. Product was also shipped to the following countries: Austria, Belgium, Canada, Czech Republic, France, Germany, Ireland, Israel, Italy, Lebanon, Saudi Arabia, South Africa, Spain, Sweden, Switzerland & United Kingdom.
  • Descripción del producto
    Tibiaxys¿ Ankle Arthrodesis Plate Compression Guide, Model #159635, part # 159 635, Batch #: EAHZ, EAJ1, ELGV, ENQE & ENQH. || Product Usage: || The Compression guide is a re-usable instrument used in the implantation of the Tibiaxys product. The Tibiaxys system is intended for fixation of bone fractures or for bone reconstruction (arthrodesis, osteotomies, and fractures of ankle joint, distal tibia and fibula).
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.