BEUDAMED
    FDA Recall Terminated

    Style 363 Saline-Filled BIOCELL textured Breast Implants

    Recall: Z-0851-05 · Initiated May 5, 2005

    Recall

    Recall Number
    Z-0851-05
    Event Number
    32063
    Firm
    Inamed Corp
    FEI Number
    2024601
    Product Code
    FWM
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    May 5, 2005
    Posted
    May 25, 2005
    Terminated
    September 2, 2011
    Address
    71 S Los Carneros Rd, Goleta, CA, 93117-5506

    Description

    Style 363 Saline-Filled BIOCELL textured Breast Implants

    Reason

    Wrong size implant was mislabeled.

    Action

    Firm sent letter by overnite mail on May 5, 2005. Follow-up phone calls were made to confirm reciept. Doctors are to review surgery records and evaluate ammount of saline used to determine the risk for folding occuring and if found a visit by the patient is recommended to further evaluate for folding.

    Distribution

    WI, TN, TX, NY, AR

    Quantity

    6