Events

Rappel de Device Recall Solanas 2.1mm FIXED DEPTH DRILL, 10mm

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 Alphatec Spine, 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
    68667
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2092-2014
  • Date de mise en oeuvre de l'événement
    2014-06-26
  • Date de publication de l'événement
    2014-07-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-09-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128421
  • 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
    Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
  • Cause
    Alphatec spine is recalling the 2.1mm fixed depth drill 10mm because they received a report that the instrument malfunctioned and golden stop slid from its fixed position during use.
  • Action
    Alphatec Spine, Inc. sent an Urgent Medical Device Notification letter dated June 20, 2014, June 26, 2014, to all affected customers. Alphatec Spine received a report of the 10mm fixed depth drill from this lot which malfunctioned and golden stop slid from its fixed position during use. The letter informs the customers of the problems identifed and the actions to be taken. Customers are instructed to confirm that they received the notification letter by completing the customer response form. Completed forms are to be sent to Alphatec Spine at 5818 El Camino Rd, Carlsbad, CA 92008. Customers may also return forms by fax at (760) 431-0289. Customers with questions were instructed to contact Alphatec Spine's Customer Service Department on how to return the affected product. For questions regarding this recall call 760-431-9286.

Device

Device Recall Solanas 2.1mm FIXED DEPTH DRILL, 10mm
  • Modèle / numéro de série
    Lot No. 7117902
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including CT, NC, AL, WV, IL, AR, and NY.
  • Description du dispositif
    Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System, a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3).
  • Manufacturer
    Alphatec Spine, Inc.

Manufacturer

Alphatec Spine, Inc.
  • Adresse du fabricant
    Alphatec Spine, Inc., 5818 El Camino Real, Carlsbad CA 92008-8816
  • Société-mère du fabricant (2017)
    Alphatec Holdings Inc.
  • Source
    USFDA