Events

Rappel de Device Recall KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System

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
    58425
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3175-2011
  • Date de mise en oeuvre de l'événement
    2011-03-23
  • Date de publication de l'événement
    2011-09-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-09-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99328
  • 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
    Arthroscope - Product Code HRX
  • Cause
    Device was shipped past the labeled expiration date.
  • Action
    On 3/23/2011, the firm initiated the recall and sent Urgent Notice: Device Recall letters identifying the affected product and explaining the reason for the recall. The letter asks customers not to use the affected product with the lot number 0001653390. The firm will replace any affected product at no cost to the customer. A Medtronic Spine Sales representative will assist with the segregation and return of the affected product. They will also assist the customer with contacting Medtronic Spine Customer Service to return the affected product. Included with the letter was a reconciliation form with instructions regarding the affected product. Questions regarding the letter should be directed to Customer Service at 866-959-7466.

Device

Device Recall KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System
  • Modèle / numéro de série
    Lot Number: 0001653390
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Kyphon brand KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System; Catalog Number: KPE1003; Product is manufactured and distributed by Medtronic Spine LLC (formerly known as Kyphon Inc), Sunnyvale, CA || Designed to reduce kyphosis that results from vertebral body collapse due to osteoporosis.
  • 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