Events

Rappel de Vilex, Inc., FUZE 10.0 mm x 250 mm, Product FZ100250T25

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 Vilex In Tennessee Inc.

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
    71344
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1723-2015
  • Date de mise en oeuvre de l'événement
    2015-04-22
  • Date de publication de l'événement
    2015-06-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-10-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137355
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Cause
    Incidence of breakage is higher than expected.
  • Action
    The initial telephone call (4/9/2015) informed the distributor that the product was on hold (not to be used or transferred). The second telephone call (4/29/2015) and letter informed the customer that the product was being removed from market and that the customer was to return the product to the corporate office. The letter was disseminated on 05/05/2015 to distributors via certified mail. The letter contains the instructions for them to follow, which as summarized are: inventory all products on hand, sign off on inventory sheet, send products back to the corporate office with the identified return number on the shipping container, inform the corporate office that the process has been completed and provide the corporate office with the list of the products returned. A second letter was disseminated to sales representatives (distributors), surgeons, and hospitals on 05/28/2015.

Device

Vilex, Inc., FUZE 10.0 mm x 250 mm, Product FZ100250T25
  • Modèle / numéro de série
    all codes
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed in the states of MS, MD, PA, and TX.
  • Description du dispositif
    Vilex, Inc., FUZE 10.0 mm x 250 mm, Product # FZ100-250T-25. || Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.
  • Manufacturer
    Vilex In Tennessee Inc

Manufacturer

Vilex In Tennessee Inc
  • Adresse du fabricant
    Vilex In Tennessee Inc, 111 Moffitt Street, Mcminnville TN 37110-2235
  • Société-mère du fabricant (2017)
    Vilex In Tennessee Inc.
  • Source
    USFDA