BEUDAMED
    FDA Recall Terminated

    Swift-Lock (TM) Anchor Accessory Kit, Directions For Use Model 1192, ANS, A St. Jude Medical Company. Product is intended to be used as an accessory to the leads component of ANS SCS systems, functioning to secure the lead to the fascia or interspinous/supraspinous ligament.

    Recall: Z-1425-2010 · Initiated February 22, 2010

    Recall

    Recall Number
    Z-1425-2010
    Event Number
    55142
    Firm
    Advanced Neuromodulation Systems, Inc
    FEI Number
    1627487
    Product Code
    GZB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 22, 2010
    Posted
    April 21, 2010
    Terminated
    July 22, 2010
    Address
    6901 Preston Rd, Plano, TX, 75024-2508

    Description

    Swift-Lock (TM) Anchor Accessory Kit, Directions For Use Model 1192, ANS, A St. Jude Medical Company. Product is intended to be used as an accessory to the leads component of ANS SCS systems, functioning to secure the lead to the fascia or interspinous/supraspinous ligament.

    Reason

    Directions For Use of product incorrectly stated lead compatibility information.

    Action

    An "Urgent Medical Device Correction" letter dated March 8, 2010, was sent to the customers (note: Firm verbally informed consignees on February 22, 2010.). The letter describes the product, problem and action to be taken by the firm -St. Jude Medical. The firm's Sales Representatives will contact the customers to update any DFUs in their possession. If you need additional copies of the insert or more information and if you have any questions or concerns, please contact your St. Jude Medical Sales Representative at 1-651-490-4470.

    Distribution

    Nationwide distribution: AZ, CA, CO, DC, FL, GA, IL, IN, MI, MO, MS, NC, NM, NJ, NV, NY, OH, OK, OR, PA, SC, TN, WA AND WV.

    Quantity

    1,120 units (218 went to doctors, remaining 902 were distributed to sales representatives)