BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-2524-2023 · Reported September 20, 2023

    Enforcement

    Recall Number
    Z-2524-2023
    Event ID
    92846
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Sofamor Danek USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 20, 2023
    Initiation Date
    July 31, 2023
    Classification Date
    September 8, 2023
    Address
    1800 Pyramid Pl, Memphis, TN, 38132-1703, United States

    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.

    Code Info

    Serial numbers: A57958-011, A57958-012, A57958-013, A57958-014, A57958-015, A57958-016, A57958-017, A57958-018, A57958-019, A57958-020, A57958-021, A57958-022, A57958-023, A57958-024, A57958-025, A57958-026, A57958-027, A57958-028, A57958-029, A57958-030, A57958-031, A57958-033, A57958-034, A57958-035, A57958-036, A57958-037, A57958-038, A57958-048, A57958-050, A57958-051, A57958-052, A57958-053, A57958-054, A57958-055, A57958-056, A57958-057, A57958-058, A57958-059, A57958-060, A57958-066, A57958-069, A57958-070, A57958-072, A57958-073, A57958-074, A57958-075, A57958-076, A57958-077, A57958-078, A57958-079, A57958-080, A57958-081, A57958-082, A57958-085, A57958- 086. Exp. 2/15/2025. UDI-DI 00613994986467

    Distribution

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

    Quantity

    55 pouches