# FDA recall Z-1897-2026

> **XTANT Medical Holdings, Inc** · Class II · device recall initiated 2026-03-09.

## 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 for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-1897-2026
- **Recalling firm:** XTANT Medical Holdings, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-09
- **Report date:** 2026-04-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Belgrade, MT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1897-2026

## Citation

> AI Analytics. FDA recall Z-1897-2026. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1897-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*