Events

Rappel de Illico 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
    63385
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0168-2013
  • Date de publication de l'événement
    2012-10-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-03-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113646
  • 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, spondylolisthesis spinal fixation - Product Code MNH
  • Cause
    The firm initiated the recall because the stainless steel guide-wire of the illico mis fixation system did not completely fit/pass through the tip of certain illico ti cannulated polyaxial screws, therefore rendering such screws nonfunctional.
  • Action
    Alphatec Spine sent an Urgent Medical Device Recall Notification letter dated September 25, 2012, to all affected customers. The letter identifed the product, the problem, and the action to be taken by the customer. Customers were instructed to contact Alphatec Spine's Customers Service Department (customerservice@alphatecspine.com) immediately for instructions on how to return the affected product. Customers were asked to fill out the lower portion of the letter and fax to (760) 431-0289 to confirm that they have read the notification and will take all necessary removal actions. For questions customers were instructed to call 1-800-922-1356. For questions regarding this recall call 760-431-9286.

Device

Illico Ti Cannulated Polyaxial Screw
  • Modèle / numéro de série
    Product Codes: KW, MNI, MNH.  Part NumberlLot Number: ¿PART DESCRIPTION LOT  7384S-30 Ti CANNULATED POLYAXIAL SCREW 4.5mm X 30mm 646501  73845-35 Ti CANNULATED POLYAXIAL SCREW 4.5mm X 35mm 646502  73845-40 Ti CANNULATED POLYAXIAL SCREW 4.5mm X 40mm 646503  73845-45 Ti CANNULATED POLYAXIAL SCREW 4.5mm X 45mm 646504  73855-35 Ti CANNULATED POLYAXIAL SCREW 5.5mm X 35mm 646510  73865-30 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 30mm 646515  73865-35 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 35mm 646516  73865-40 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 40mm 646517  73865-45 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 45mm 646542  73865-50 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 50mm 646543  73875-35 Ti CANNULATED POLYAXIAL SCREW 7.5mm X 35mm 646546  73875-45 Ti CANNULATED POLYAXIAL SCREW 7.5mm X 45mm 646548  73875-50 Ti CANNULATED POLYAXIAL SCREW 7.5mm X 50mm 646549
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including AZ, IL, CA, SC, TN, TX, GA, CT, NY, FL, OK, LA, MO, NV,and UT.
  • Description du dispositif
    ILLlCO¿ MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System, || Orthosis, Spinal Pedical Fixation || Orthosis, Spondylolisthesis Spinal Fixation || 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. When used for a minimally invasive posterior approach ILLlCO¿ MIS Instrumentation is used in conjunction with polyaxial screw components. The ILLICO MIS Posterior Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the ILLICO MIS Posterior Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.
  • 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