BEUDAMED
    FDA Recall Open, Classified

    Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.

    Recall: Z-2524-2023 · Initiated July 31, 2023

    Recall

    Recall Number
    Z-2524-2023
    Event Number
    92846
    Firm
    Medtronic Sofamor Danek USA Inc
    FEI Number
    1000477302
    Product Code
    MQV
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    July 31, 2023
    Posted
    September 8, 2023
    Address
    1800 Pyramid Pl, Memphis, TN, 38132-1703

    Description

    Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.

    Reason

    The incorrect product labeling was applied to the product indicating the wrong size of product.

    Action

    Beginning 7/31/2023, In the U.S. Medtronic initiated a Consignee Notification and Customer Confirmation Form via UPS 2-Day delivery to each listed consignee. Consignees were asked to quarantine and return any affected unused product they may have and complete and return the Customer Confirmation Form (i.e. reply form). Additionally, consignees were asked to forward this notification to those who need to be aware within the organization or to any location which the devices have been transferred.

    Distribution

    US Nationwide distribution in the states of ID, IN, MN, NC, NY, OH, OR, WA, and WI.

    Quantity

    55 pouches