Events

Rappel de Device Recall SpineNet Anterior Cervical Cage

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 SpineNet.

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
    65917
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2103-2013
  • Date de mise en oeuvre de l'événement
    2013-02-05
  • 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
    2014-05-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120864
  • 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
    The recall decision has been made because because it has recently been determined that the instructions for use (ifu) had certain statements that should have been removed prior to initial product marketing.
  • Action
    SpineNET sent a Customer Notification letter dated 02/05/2013 to their only customer (Halifax Medical Center). The letter identified the affected product, problem and actions to be taken. Customers were informed to remove any copies of the original IFU-ACC-01 form from their records and replace with the IFU-ACC-02 form attached to the letter. For questions contact SpineNET office directly.

Device

Device Recall SpineNet Anterior Cervical Cage
  • Modèle / numéro de série
    Ref. No. CL1012-05 Size 10mm x 12mm x 5mm, Ref. No. CL1012-06 Size 10mm x 12mm x 6mm, Ref. No. CL1012-07 Size 10mm x 12mm x 7mm, Ref. No. CL1012-08 Size 10mm x 12mm x 8mm, Ref. No. CL1012-09 Size 10mm x 12mm x 9mm, Ref. No. CL1012-10 Size 10mm x 12mm x 10mm, Ref. No. CL1014-05 Size 12mm x 14mm x 5mm, Ref. No. CL1014-06 Size 12mm x 14mm x 6mm, Ref. No. CL1014-07 Size 12mm x 14mm x 7mm, Ref. No. CL1014-08 Size 12mm x 14mm x 8mm, Ref. No. CL1014-09 Size 12mm x 14mm x 9mm, and Ref. No. CL1014-10 Size 12mm x 14mm x 10mm.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    USA Nationwide Distribution in the state of Florida
  • Description du dispositif
    SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage) || Product Usage: Is indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level
  • Manufacturer
    SpineNet

Manufacturer

SpineNet
  • Adresse du fabricant
    SpineNet, 1300 Minnesota Ave, Suite 200, Winter Park FL 32789-4800
  • Société-mère du fabricant (2017)
    Spinenet Llc
  • Source
    USFDA