BEUDAMED
    FDA Recall Terminated

    McGhan Style 40, Round Breast Implant, Standard Projection, Silicone-filled Smooth INTRASHIEL Barrier Catalog Numbers: 25-40401 25-40461 25-40501 25-40561

    Recall: Z-0006-04 · Initiated September 12, 2003

    Recall

    Recall Number
    Z-0006-04
    Event Number
    27294
    FEI Number
    2024601
    Product Code
    FTR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 12, 2003
    Posted
    October 15, 2003
    Terminated
    March 7, 2012
    Address
    Inamed Corp 71 S, Los Carneros Goleta, CA, 93117

    Description

    McGhan Style 40, Round Breast Implant, Standard Projection, Silicone-filled Smooth INTRASHIEL Barrier Catalog Numbers: 25-40401 25-40461 25-40501 25-40561

    Reason

    The 400cc, 460cc, 500cc and 560cc sizes of the McGhan Style 40 Silicone-filled Breast Implants were manufactured using one size smaller shells than required.

    Action

    Recall was by letter to surgeons on 9/12/2003 which ask for return of unimplanted devices and an accounting of what is to be returned.

    Distribution

    Nationwide and Canada.

    Quantity

    694