BEUDAMED
    FDA Enforcement Class II Terminated

    Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. The product is packaged in a thermoformed tray (double sterile barrier) and enclosed in a labeled carton.

    Recall: Z-1988-2015 · Reported July 15, 2015

    Enforcement

    Recall Number
    Z-1988-2015
    Event ID
    71428
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Allergan Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 15, 2015
    Initiation Date
    June 8, 2015
    Classification Date
    July 7, 2015
    Termination Date
    December 16, 2015
    Address
    2525 Dupont Dr, N/A, Irvine, CA, 92612-1531, United States

    Description

    Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. The product is packaged in a thermoformed tray (double sterile barrier) and enclosed in a labeled carton.

    Reason

    Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired product was shipped to the user level.

    Code Info

    Lot # Serial # Style #: 1703043, 14124459, MSZFX410; 1708499, 14164655, MSZFX410; 1801072, 14768661, MSZFX410; 1819375, 14905528, MSZFX410; 1819377, 14911183, MSZFX410; 1819377, 14911197, MSZFX410; 1819377, 14911180, MSZFX410; 1819378, 14907262, MSZFX410; 1819378, 14907266, MSZFX410.

    Distribution

    CA, IN, MO, NJ, VA

    Quantity

    9 units