BEUDAMED
    FDA Recall Terminated

    TefGen is an implant material which is intended to be used as a temporary space-making barrier over bone or other tissue.

    Recall: Z-1073-04 · Initiated June 3, 2004

    Recall

    Recall Number
    Z-1073-04
    Event Number
    29382
    Firm
    Lifecore Biomedical, Inc.
    FEI Number
    1000115753
    Product Code
    LYC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 3, 2004
    Posted
    July 20, 2004
    Terminated
    July 22, 2006
    Address
    3515 Lyman Blvd, Chaska, MN, 55318

    Description

    TefGen is an implant material which is intended to be used as a temporary space-making barrier over bone or other tissue.

    Reason

    Packaged product labeled catalog #TFS30, lot number 002419 actually contained catalog #TFR60, lot number 002441and vice versa.

    Action

    Each facility was notified of the recall by letter on 06/03/2004.

    Distribution

    Throughout the U.S., Germany, France, Korea, Columbia, Chile and Korea

    Quantity

    200 of lot #002419 and 55 of lot #002441