BEUDAMED
    FDA Enforcement Class II Terminated

    MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.

    Recall: Z-0279-2016 · Reported November 25, 2015

    Enforcement

    Recall Number
    Z-0279-2016
    Event ID
    72552
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Astora
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    November 25, 2015
    Initiation Date
    October 26, 2015
    Classification Date
    November 16, 2015
    Termination Date
    March 9, 2016
    Address
    13200 Pioneer Trl, N/A, Eden Prairie, MN, 55347-4119, United States

    Description

    MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.

    Reason

    The lot number on the outer carton label did not match the lot number printed on the tray label or identification labels inside the box. The identification labels inside the box are placed on medical records and other documents associated with the procedure. Use of incorrectly identified labels may prevent direct traceability of the implanted unit in the future.

    Code Info

    Lot number 936405. Serial numbers 936405001 through 936405056

    Distribution

    Distributed in the states of AZ, CA, DE, IL, KS, NE, NJ, NY, OH, PA, TX

    Quantity

    52