BEUDAMED
    FDA Enforcement Class II Terminated

    Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cm Ref. ACE36E Lot 122295, 122308, 122762 Unclassified

    Recall: Z-1644-2013 · Reported July 10, 2013

    Enforcement

    Recall Number
    Z-1644-2013
    Event ID
    65205
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Surgical Instrument Service And Savings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 10, 2013
    Initiation Date
    May 3, 2013
    Classification Date
    July 1, 2013
    Termination Date
    July 11, 2013
    Address
    2747 Sw 6th St, N/A, Redmond, OR, 97756-7109, United States

    Description

    Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cm Ref. ACE36E Lot 122295, 122308, 122762 Unclassified

    Reason

    The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

    Code Info

    122295, 122308, 122762.

    Distribution

    Nationwide Distribution.

    Quantity

    3