Events

Recall of KyphX Xpander

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Kyphon Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    27597
  • Event Risk Class
    Class 2
  • Event Number
    Z-0146-04
  • Event Initiated Date
    2003-10-13
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-03-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30157
  • Notes / Alerts
    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.
  • Extra notes in the data
    Injector And Syringe, Angiographic - Product Code DXT
  • Reason
    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
  • Model / Serial
    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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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
  • Manufacturer Address
    Kyphon Inc, 1350 Bordeaux Dr, Sunnyvale CA 94089-1005
  • Source
    USFDA