Events

Rappel de Device Recall KyphX Xpander Inflatable Bone Tamp, size 15/3

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 Medtronic Spine LLC, formerly Kyphon 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
    51206
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1209-2009
  • Date de mise en oeuvre de l'événement
    2009-02-04
  • Date de publication de l'événement
    2009-05-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-07-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79178
  • 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
    spinal bone tamp - Product Code HRX
  • Cause
    Product not sterile: 10 units were released for distribution without undergoing sterilization process.
  • Action
    Sales representatives were contacted via e-mail on February 4, 2009, and instructed to contact hospitals and inform them of the issue and sequester affected product. They were further instructed to immediately travel to the hospitals and obtain affected product for return to Medtronic LLC. A Customer Communication Notice URGENT NOTICE: DEVICE REMOVAL dated February 9, 2009, was sent to the two consignees.

Device

Device Recall KyphX Xpander Inflatable Bone Tamp, size 15/3
  • Modèle / numéro de série
    Catalog number K09A, Lot number 50000231, UPN 00858196001161.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product was distributed to two hospitals in OH and FL.
  • Description du dispositif
    KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Number K09A, Manufactured by Kyphon Sarl, Switzerland. For use in spinal surgery.
  • Manufacturer
    Medtronic Spine LLC, formerly Kyphon Inc

Manufacturer

Medtronic Spine LLC, formerly Kyphon Inc
  • Adresse du fabricant
    Medtronic Spine LLC, formerly Kyphon Inc, 1221 Crossman Ave, Sunnyvale CA 94089-1103
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA