Events

Rappel de Device Recall Tibiaxys Ankle Arthrodesis Plate Compression Guide

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Integra LifeSciences Corp..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    61041
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1144-2012
  • Date de mise en oeuvre de l'événement
    2011-11-17
  • Date de publication de l'événement
    2012-03-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-02-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107319
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Ankle arthroplasty implantation system - Product Code OYK
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    Model #159635, part # 159 635, Batch #: EAHZ, EAJ1, ELGV, ENQE & ENQH.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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.