BEUDAMED
    FDA Recall Open, Classified

    Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g) DB-5000

    Recall: Z-2228-2021 · Initiated June 2, 2021

    Recall

    Recall Number
    Z-2228-2021
    Event Number
    88160
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    GXR
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    June 2, 2021
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

    Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g) DB-5000

    Reason

    Excess nylon flash on the clip.

    Action

    On June 2,2021 the firm sent letter with the following information: Dear Healthcare Professional, Medtronic is voluntarily recalling specific lots of the StimLoc" Burr Hole Cover due to a manufacturing issue resulting in excess nylon flash on the clip. Please review the information contained in this letter, quarantine any affected product (see Attachment A for list of affected lot numbers) in your inventory for return to Medtronic, and sign and return the customer confirmation form included with this letter. Medtronic email at [email protected] or Medtronic Technical Services at 1-800-707-0933 weekdays 7am - 6pm CST.

    Distribution

    AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and Hawaii

    Quantity

    15,192