nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced
FDA device recall Z-1897-2026 · posted 2026-04-21 · Open, Classified
Recall details
- Recalling firm
- XTANT Medical Holdings, Inc
- Reason for recall
- Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
- Action taken
- 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.
- Root cause
- Incorrect or no expiration date
- Status
- Open, Classified
- Product code
- MQV
- Quantity affected
- 225
- Distribution
- US Nationwide distribution in the states and territories of CA, CT, DC, KS, MD, NC, NY, TX, and WI.
- Date initiated
- 2026-03-09
- Date posted
- 2026-04-21
- Location
- Belgrade, MT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NB3D BONE VOID FILLER (K132050) | Pioneer Surgical Technology, Inc. | 2014-02-07 |