BEUDAMED
    FDA Recall 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 · Initiated March 18, 2019

    Recall

    Recall Number
    Z-2219-2019
    Event Number
    83251
    Firm
    Ideal Implant Incorporated
    FEI Number
    3008342021
    Product Code
    FWM
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 18, 2019
    Terminated
    March 3, 2021
    Address
    14881 Quorum Dr, Ste 925, Dallas, TX, 75254-7132

    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.

    Action

    The recall was initiated via telephone and email on 3/18/2019 to one consignee and via email on 3/22/2019 to the other consignees and requested return of the implants.

    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