Events

Rappel de Device Recall Drill Guide (guide, surgical, instrument)

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 SpineFrontier, 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
    64985
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1871-2013
  • Date de mise en oeuvre de l'événement
    2012-11-09
  • Date de publication de l'événement
    2013-08-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-06-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117583
  • 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
    Guide surgical instrument - Product Code FZX
  • Cause
    Prior to use in surgery, the drill guides were presenting noticeable degrees of denting and/or bending. as a result, drills and taps could not be directed down guides during surgery due to mechanical interference.
  • Action
    Spine Frontier sent an Advisory Notice dated November 9, 2012, via email to all affected customers. Customers were advised that their FacetFuse Drill Guides need to be replaced. Customers were instructed to write their number ( included in the email) on the outside of the package and provide us with the tracking information. A replacement part has been sent out to you. If you have any further questions please call (978) 232-3990.

Device

Device Recall Drill Guide (guide, surgical, instrument)
  • Modèle / numéro de série
    2520301, 2520307
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution including Puerto Rico and the states of CO, KS, MA and TX.
  • Description du dispositif
    Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A || FacetFuse Drill Guides were designed to provide a concentric pathway for the drills and taps to access the bone while protecting the soft tissue from the cutting geometry of the drills/taps. In addition the drill guide is used as a reference to measure depth that the drills and taps are protruding into bone, which is measured by depth markings at the proximal end of the drills/taps relative to the proximal end of the drill guide. These devices were used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients.
  • Manufacturer
    SpineFrontier, Inc.

Manufacturer

SpineFrontier, Inc.
  • Adresse du fabricant
    SpineFrontier, Inc., 500 Cummings Ctr Ste 3500, Beverly MA 01915-6516
  • Société-mère du fabricant (2017)
    SpineFrontier, Inc.
  • Source
    USFDA