BEUDAMED
    FDA Recall Terminated

    TraXis Vue Spinal Implant System, Part #2601-090921

    Recall: Z-0502-06 · Initiated November 2, 2005

    Recall

    Recall Number
    Z-0502-06
    Event Number
    34014
    Firm
    Abbott Spine
    FEI Number
    3000718496
    Product Code
    MQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 2, 2005
    Posted
    February 7, 2006
    Terminated
    September 25, 2007
    Address
    12708 Riata Vista Cir, # B-100, Austin, TX, 78727-7167

    Description

    TraXis Vue Spinal Implant System, Part #2601-090921

    Reason

    Implants were manufactured without radiographic markers.

    Action

    Firm initiated phone contact of all Sales Representatives who received lot and surgeons who have implanted lot on 11/02/05. Recall Letters to be sent to surgeons who have implanted affected lot.

    Distribution

    Nationwide. Implants distributed to Sales Representatives in AZ, CA, FL, GA, KY, IL, MA, NY, OK, PA, TX, UT, VA and WI.

    Quantity

    41 units