Events

Rappel de KyphX Xpander

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 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
    27597
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0146-04
  • Date de mise en oeuvre de l'événement
    2003-10-13
  • Date de publication de l'événement
    2004-07-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2004-03-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30157
  • 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
    Injector And Syringe, Angiographic - Product Code DXT
  • Cause
    Devices for which sterility may be compromised as evidenced by a loss of package integrity.
  • Action
    On October 13, 2003, all consignees were notified via letter and on-site visit by a Kyphon sales representative, informing them of the affected devices and providing instructions on the recall.

Device

KyphX Xpander
  • Modèle / numéro de série
    Merit Medical (Inflation Syringe): Part No.: K05-01290A, Lot Nos.:A284998, A282736*; Kyphon (Inflation Syringe), Catalog No.: A08A, Lot Nos.: A284998, A282736.  *Although Merit Medical''s notice of the recall involved three (3) lot numbers, one of the lots had already been returned by Kyphon to Merit Medical upon Kyphon''s discovery during incoming inspection that there was a problem with the packaging. So, Kyphon''s product removal only involved the two (2) additional lots of syringes, only portions of which were distributed to customers.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    There were a total of 188 direct customers that received the recalled product distributed by Kyphon. There were 0 (zero) wholesaler dealers, distributors, retailers that received the recalled product distributed by Kyphon. The recalled product was distributed in the United States only. Recalled product was distributed by Kyphon to one VA hospital, VA Medical Center of San Diego, 3350 La Jolla Village Dr. San Diego, CA 92161. There were no shipments to foreign or Canadian distribution.
  • Description du dispositif
    KyphX Xpander brand Inflation Syringe; Merit Medical Part Number: K05-01290A. || Kyphon Catalog Number: A08A. The medical device is distributed by Kyphon under the brand name KyphX Xpander Inflation Syringe. This medical device is provided as an individual stand-alone package (which also contains an accessory locking syringe device) and as an individually packaged component of the KyphoPak Tray. The Inflation Syringe packaging and contents are identical whether provided as a stand-alone package or as a component of the KyphoPak Tray.
  • Manufacturer
    Kyphon Inc

Manufacturer

Kyphon Inc
  • Adresse du fabricant
    Kyphon Inc, 1350 Bordeaux Dr, Sunnyvale CA 94089-1005
  • Source
    USFDA