BEUDAMED
    FDA Recall Terminated

    Spacers of varying lengths used with the InSTANT Stranding System, Part numbers: TG3138, TG3139, TG3140, TG3141 and TG3142. Theragenics Corporation, 5203 Bristol Industrial Way, Buford GA 30518. The spacer product is intended for consumption during the brachytherapy procedure. Unused (unopened) product is not intended to be inventoried. by the attending physician.

    Recall: Z-1020-2009 · Initiated December 8, 2008

    Recall

    Recall Number
    Z-1020-2009
    Event Number
    51177
    Firm
    Theragenics Corporation
    FEI Number
    1037598
    Product Code
    NQO
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    December 8, 2008
    Posted
    March 31, 2009
    Terminated
    April 6, 2009
    Address
    5203 Bristol Industrial Way, Buford, GA, 30518

    Description

    Spacers of varying lengths used with the InSTANT Stranding System, Part numbers: TG3138, TG3139, TG3140, TG3141 and TG3142. Theragenics Corporation, 5203 Bristol Industrial Way, Buford GA 30518. The spacer product is intended for consumption during the brachytherapy procedure. Unused (unopened) product is not intended to be inventoried. by the attending physician.

    Reason

    Some pouches were found to have weak seals potentially compromising sterility.

    Action

    Consignees were notified first by telephone on December 8, 2008 and sent a follow up letter dated January 13, 2009. They were instructed to return any of the affected lots remaining in their inventory.

    Distribution

    Nationwide Distribution -- states of VA, WI, and CO.

    Quantity

    62 units