BEUDAMED
    FDA Enforcement Class II Terminated

    IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc, 440cc, 475cc, 515cc, 555cc, 595cc, 635cc, and 675cc.

    Recall: Z-2219-2019 · Reported August 14, 2019

    Enforcement

    Recall Number
    Z-2219-2019
    Event ID
    83251
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ideal Implant Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 14, 2019
    Initiation Date
    March 18, 2019
    Classification Date
    August 8, 2019
    Termination Date
    March 3, 2021
    Address
    14881 Quorum Dr Ste 925, N/A, Dallas, TX, 75254-7132, United States

    Description

    IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc, 440cc, 475cc, 515cc, 555cc, 595cc, 635cc, and 675cc.

    Reason

    The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly after implantation.

    Code Info

    Serial numbers between 0100292 and 0102777.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, ND, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. Country of Canada.

    Quantity

    1,704 implants