BEUDAMED
    FDA Recall Terminated

    Plicator EPS Plication System Catalog Number: 160-01128R

    Recall: Z-0685-2007 · Initiated January 26, 2007

    Recall

    Recall Number
    Z-0685-2007
    Event Number
    37247
    Firm
    NDO Surgical, Inc.
    FEI Number
    3003309251
    Product Code
    KOG
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    January 26, 2007
    Posted
    March 31, 2007
    Terminated
    December 12, 2007
    Address
    125 High St, Ste 7, Mansfield, MA, 02048-2165

    Description

    Plicator EPS Plication System Catalog Number: 160-01128R

    Reason

    Device arm may fail to open after being deployed and require surgical intervention to remove

    Action

    NDO Surgical notified accounts by letter on 1/26/07 advising to quarantine units. Replacement units are being sent and recalled devices are requested to be returned.

    Distribution

    Worldwide distribution, USA including states of AZ, GA, NH, NY, TN and country of Germany.

    Quantity

    9 units