Recall Z-1897-2026— XTANT Medical Holdings, Inc
Class II · Ongoing
Class II FDA medical device recall by XTANT Medical Holdings, Inc, initiated 2026-03-09. It names one FDA 510(k) clearance: K132050. Product: 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..
- Recalling firm
- XTANT Medical Holdings, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-03-09
- Firm location
- Belgrade, MT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 for recall
Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
Data sourced from openFDA. This site is unofficial and independent of the FDA.