Events

Rappel de CPlus

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 RTI Surgical, 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
    67093
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0627-2014
  • Date de mise en oeuvre de l'événement
    2013-10-07
  • Date de publication de l'événement
    2014-01-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-02-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124694
  • 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
    Intervertebral fusion device with bone graft, cervical - Product Code ODP
  • Cause
    As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm webless c-plus implants were incorrectly documented as meeting the requirement for labeling as a partial vertebral body replacement device (vbr). while the use of this device as a partial vbr is unlikely due to the size of the device, use of this device as a partial vbr could result in a s.
  • Action
    RTI Surgical, Inc. sent an Important Notice letter dated October 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed remove fall affected product from their inventory and send back to Customers Service at 375 River Park Circle, Marquette, MI 49855 by October 16, 2013. Customers with questions were instructed to call 906-226-4489. For questions regarding this recall call 906-226-4812.

Device

CPlus
  • Modèle / numéro de série
    part numbers: 30-CW-1012-5, 30-CW-1012-6, 30-CW-1012-7, 30-CW-1012-8, 30-CW-1012-9, 30-CW-1 012-10, 30-CW-1 012-11.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution - USA including FL, MO, NY, CA, MI,and IL.
  • Description du dispositif
    C-Plus" 10mm x 12mm Webless implants || Pioneer Surgical's C-Plus " 10mm x 12mm Webless implants are cervical intervertebral fusion devices that are intended to stabilize a cervical spinal segment to promote fusion in order to restrict motion and decrease pain. They are intended for use with supplemental fixation and autograft. These implants are manufactured from PEEK (Polyaryletheretherketone) polymer with tantalum marker pins for radiographic visualization.
  • Manufacturer
    RTI Surgical, Inc.

Manufacturer

RTI Surgical, Inc.
  • Adresse du fabricant
    RTI Surgical, Inc., 375 River Park Cir, Marquette MI 49855-1781
  • Société-mère du fabricant (2017)
    RTI Surgical Inc
  • Source
    USFDA