BEUDAMED
    FDA Enforcement Class II Terminated

    Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.

    Recall: Z-0377-2014 · Reported December 4, 2013

    Enforcement

    Recall Number
    Z-0377-2014
    Event ID
    66561
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mizuho America, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2013
    Initiation Date
    October 10, 2013
    Classification Date
    November 22, 2013
    Termination Date
    January 13, 2014
    Address
    30057 Ahern Ave, N/A, Union City, CA, 94587-1234, United States

    Description

    Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.

    Reason

    Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored.

    Code Info

    Product Code 17-001-56; Lot No. 27JY

    Distribution

    Nationwide Distribution

    Quantity

    32