BEUDAMED
    FDA Recall Terminated

    McGhan Style 163-360cc Saline-Filled BIOCELL textured Breast Implants, Catalogue Number :163-360

    Recall: Z-0337-06 · Initiated December 14, 2005

    Recall

    Recall Number
    Z-0337-06
    Event Number
    34256
    Firm
    Inamed Corp
    FEI Number
    2024601
    Product Code
    FWM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 14, 2005
    Posted
    December 31, 2005
    Terminated
    January 29, 2007
    Address
    71 S Los Carneros Rd, Goleta, CA, 93117-5506

    Description

    McGhan Style 163-360cc Saline-Filled BIOCELL textured Breast Implants, Catalogue Number :163-360

    Reason

    Two lots of products were mislabeled; a lot of twenty Style 468 Breast Implants and a lot of twenty Style 163 Breast Implants. In error, the labels for these two lots were switched during packaging. As a result, a total of 40 devices were mislabeled.

    Action

    On Wednesday, 14-December-2005, Inamed began calling affected customers to notify them of the voluntary recall. At the end of business on Wednesday, 14-December-2005, Inamed distributed Recall Notification Letters via Federal Express overnight mail directly to affected customers.

    Distribution

    Nationwide

    Quantity

    2