Events

Rappel de Device Recall lllico Ti Cannulated Polyaxial Screw

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
    65672
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2086-2013
  • Date de mise en oeuvre de l'événement
    2013-06-28
  • Date de publication de l'événement
    2013-08-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-10-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119844
  • 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
    The firm initiated this recall of certain lots of illico ti cannulated polyaxial screws 7.5mm x 40mm implants, due to an off-center cannulation hole at the proximal end of the bone screw. there is a potential risk that when the screw is mated to a polyaxial screwdriver, the guide wire may not pass through the screwdriver.
  • Action
    The firm, Alphatec Spine, sent an "URGENT-MEDICAL DEVICE RECALL NOTIFICATION" with response sheet dated June 28, 2013 via a combination of e-mail, Fedex, and telephone contact to its customers. The notification described the product, problem and actions to be taken. The customers were instructed to immediately return any and all affected lots of the illico Ti Cannulated Polyaxial Screw 7.5 mm x 40 mm implants that have been sent to them; if the device has previously been implanted, there is no further or additional risk post-implantation; immediately contact Alphatec Spine Customer Service Department - customerservice@alphatecspine.com on how to replace the implants; and complete and return the last page of the notification via mail to Alphatec Spine, Inc. 5818 El Camino Real, Carlsbad, CA 92008; email: sarrhenius@alphatecspine or fax to: (760) 431-0289. If you have any questions or need any additional information, please contact Director of Compliance at 760-494-9636 or email at dmcgrath@alphatecspine.com.

Device

Device Recall lllico Ti Cannulated Polyaxial Screw
  • Modèle / numéro de série
    Part Number 73875-40. Lots Affected:  647289, 648923, 649244, 649556, 649813, 650040, 650262, 650589.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution: US (nationwide) including states of:US states: AZ, CA, FL, GA, IL, MD, NJ, NY, OK, PA, TN, TX,and WA ; and countries of: Spain, France, Japan. International: Spain, France, Japan.
  • Description du dispositif
    Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.
  • 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