Medical device recalls Moderate risk

XTANT Medical Holdings, Inc recalls nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advance…

Recall date
March 9, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1897-2026
FDA classification
Class II
Brand / firm
XTANT Medical Holdings, Inc
Sold / distributed
US Nationwide distribution in the states and territories of CA, CT, DC, KS, MD, NC, NY, TX, and WI.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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