BEUDAMED
    FDA Recall Open, Classified

    nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft Substitute, 25x100x8mm, 20cc 90-300-25508: nanOss 3D Advanced Bone Graft Substitute, 25x50x8mm, 10cc 90-300-251004: nanOss 3D Advanced Bone Graft Substitute, 25x100x4mm, 10cc 90-400-25508: nanOss 3D Plus Advanced Bone Graft Substitute, 25x50x8mm, 10cc

    Recall: Z-1897-2026 · Initiated March 9, 2026

    Recall

    Recall Number
    Z-1897-2026
    Event Number
    98643
    Firm
    XTANT Medical Holdings, Inc
    FEI Number
    3005031160
    Product Code
    MQV
    Status
    Open, Classified
    Root Cause
    Incorrect or no expiration date
    Initiated
    March 9, 2026
    Posted
    April 21, 2026
    Address
    664 Cruiser Ln, Belgrade, MT, 59714-9719

    Description

    nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft Substitute, 25x100x8mm, 20cc 90-300-25508: nanOss 3D Advanced Bone Graft Substitute, 25x50x8mm, 10cc 90-300-251004: nanOss 3D Advanced Bone Graft Substitute, 25x100x4mm, 10cc 90-400-25508: nanOss 3D Plus Advanced Bone Graft Substitute, 25x50x8mm, 10cc

    Reason

    Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.

    Action

    On March 9, 2026, the firm began notifying customers via letters titled "URGENT: MEDICAL DEVICE RECALL." Customers were instructed to segregate and quarantine all affected products to prevent use, and discontinue use of any affected product. Affected product must be returned to Xtant Medical.

    Distribution

    US Nationwide distribution in the states and territories of CA, CT, DC, KS, MD, NC, NY, TX, and WI.

    Quantity

    225