Irix-A Integrated Lumbar Fusion System — Class II medical device recall Z-1177-2025
Ongoing recall by XTANT Medical Holdings, Inc, reported 2025-02-26, distributed nationwide. Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiratio
| Recall number | Z-1177-2025 |
|---|---|
| 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 | 2025-01-03 |
| Classified | 2025-02-19 |
| Reported by FDA | 2025-02-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU |
| Quantity | 14 units |
| Reason classes | labeling |
| Lot numbers | 053028, 054961 |
| Model numbers | X080-382819-08PC, X080-382819-08PC-STR, X080-423011-08PC, X080-423011-08PC-STR |
Product
Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) and Model Number X080-382819-08PC (Spacer ASSY, 38 X 28 X 8¿, 19mm, PC, (STERILE))
Reason for recall
Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
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-1177-2025. 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.