BEUDAMED
    FDA Recall Terminated

    KyphX Osteo Introducer System with blunt tip introducer stylet (as contained in the KyphoPak Tray, First Fracture, 15/3 Xpander), catalog number KPT1502, manufactured by Medtronic Spine LLC. Device is used to access vertebral body during balloon kyphoplasty, a procedure designed to reduce and stabilize vertebral body compression fractures (VCFS).

    Recall: Z-2347-2008 · Initiated June 23, 2008

    Recall

    Recall Number
    Z-2347-2008
    Event Number
    48988
    Firm
    Kyphon Inc
    FEI Number
    3004904811
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    June 23, 2008
    Posted
    September 18, 2008
    Terminated
    October 7, 2009
    Address
    1221 Crossman Ave, Sunnyvale, CA, 94089-1103

    Description

    KyphX Osteo Introducer System with blunt tip introducer stylet (as contained in the KyphoPak Tray, First Fracture, 15/3 Xpander), catalog number KPT1502, manufactured by Medtronic Spine LLC. Device is used to access vertebral body during balloon kyphoplasty, a procedure designed to reduce and stabilize vertebral body compression fractures (VCFS).

    Reason

    Some products may contain the incorrect introducer stylet. If the treating physician is unfamiliar with the use and design of the diamond tip stylet, there is a possibility of serious injuring occurring with the use of the diamond tip stylet during balloon kyphoplasty procedure. Other risks include delay to surgery and inconvenience to patient.

    Action

    Recall initiated on June 23, 2008. A recall letter and reconciliation form was sent out via e-mail to sales representatives for hand delivery to US hospital consignees. The consignees were asked to review the letter and complete/return the reconciliation form to the firm. If you have any questions contact Kyphon, Inc. at 1-408-548-6740.

    Distribution

    Class II Recall - Nationwide Distribution.

    Quantity

    310 units