nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone… — Class II medical device recall Z-1897-2026
Ongoing recall by XTANT Medical Holdings, Inc, reported 2026-04-29, distributed nationwide. Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four year
| Recall number | Z-1897-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | XTANT Medical Holdings, Inc, Belgrade, MT, United States |
| Recall initiated | 2026-03-09 |
| Classified | 2026-04-21 |
| Reported by FDA | 2026-04-29 |
| Distributed | Nationwide (US) |
| Quantity | 225 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00849777012461, 00849777012478, 00849777012492, 00849777012539 |
| Lot numbers | 385486-RP25-0080, 387070-RP25-0081, 387071-RP25-0083, 401347-RP25-0070, 415871-RP25-0073, 415872-RP25-0074, 415971-RP25-0077, 416678-RP25-0072, 416679-RP25-0071, 418098-RP25-0084, 418509-RP25-0075, 436199-RP25-0085, 436563-RP25-0082, 436564-RP25-0079, 436565-RP25-0076, 444927-RP25-0078, 445442-RP25-0128 |
| Model numbers | 90-300-251004, 90-300-251008, 90-300-25508, 90-400-25508 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1897-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.