BEUDAMED
    FDA Recall Terminated

    McGhan Round Breast Implant, Saline-Filled BIOCELL textured. McGhan Shaped Breast Implant Saline Filled BIOCELL textured.

    Recall: Z-1216-03 · Initiated August 1, 2003

    Recall

    Recall Number
    Z-1216-03
    Event Number
    27022
    FEI Number
    2024601
    Product Code
    FWM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 1, 2003
    Posted
    September 11, 2003
    Terminated
    September 10, 2003
    Address
    Inamed Corp 71 S, Los Carneros Goleta, CA, 93117

    Description

    McGhan Round Breast Implant, Saline-Filled BIOCELL textured. McGhan Shaped Breast Implant Saline Filled BIOCELL textured.

    Reason

    Labeling mixup.

    Action

    Implants were requested back by telephone. They were returned at the firm''s expense. Recall is complete.

    Distribution

    Tenessee.

    Quantity

    4