BEUDAMED
    FDA Enforcement Class II Terminated

    Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048

    Recall: Z-2070-2017 · Reported May 17, 2017

    Enforcement

    Recall Number
    Z-2070-2017
    Event ID
    76868
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mentor Texas, LP.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 17, 2017
    Initiation Date
    March 27, 2017
    Classification Date
    May 11, 2017
    Termination Date
    June 13, 2017
    Address
    3025 Skyway Cir N, N/A, Irving, TX, 75038-3524, United States

    Description

    Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048

    Reason

    Missing Dome Pack accessory.

    Code Info

    Lot Number: 7377332

    Distribution

    US Distribution to the states of : MI, CA, CT, IL, IN, NY, NC, OH and OK.

    Quantity

    28 units