BEUDAMED
    FDA Recall Terminated

    TraXis Fixed Trial in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; part of TraXis vertebral body replacement system

    Recall: Z-0354-2007 · Initiated November 7, 2006

    Recall

    Recall Number
    Z-0354-2007
    Event Number
    36731
    Firm
    Abbott Spine
    FEI Number
    3000718496
    Product Code
    MQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 7, 2006
    Posted
    January 17, 2007
    Terminated
    October 11, 2007
    Address
    12708 Riata Vista Cir, # B-100, Austin, TX, 78727-7167

    Description

    TraXis Fixed Trial in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; part of TraXis vertebral body replacement system

    Reason

    Tip of devices may dislodge while in use during surgery.

    Action

    All consignees that have the affected TraXis Fixed Rasps and TraXis Fixed Trials will be contacted via a documented phone script 11/07/2006. Affected inventory will be exchanged for re-worked instruments.

    Distribution

    Worldwide, including USA, Spain, Mexico, United Kingdom, Germany, and Cyprus

    Quantity

    76 units.