BEUDAMED
    FDA Recall Terminated

    KyphXR brand KyphoPak Tray, a Introducer Tool kit for Inflation Syringe Kyphon Catalog Number: KPT1001, KPT1002, KPT1003, KPT1501, KPT1503, KPT2002, KPT2003 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.

    Recall: Z-0147-04 · Initiated October 13, 2003

    Recall

    Recall Number
    Z-0147-04
    Event Number
    27597
    Firm
    Kyphon Inc
    FEI Number
    3004904811
    Product Code
    DXT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 13, 2003
    Posted
    July 20, 2004
    Terminated
    March 8, 2004
    Address
    1350 Bordeaux Dr, Sunnyvale, CA, 94089-1005

    Description

    KyphXR brand KyphoPak Tray, a Introducer Tool kit for Inflation Syringe Kyphon Catalog Number: KPT1001, KPT1002, KPT1003, KPT1501, KPT1503, KPT2002, KPT2003 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.

    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.

    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.

    Quantity

    771 syringes