Cortera Spinal Fixation System Screw — Class II medical device recall Z-0125-2025
Ongoing recall by XTANT Medical Holdings, Inc, reported 2024-10-23, distributed nationwide. Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manu
| Recall number | Z-0125-2025 |
|---|---|
| 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 | 2024-08-21 |
| Classified | 2024-10-17 |
| Reported by FDA | 2024-10-23 |
| Distributed | Nationwide (US) |
| Quantity | 330 |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00810076563190 |
| Model numbers | 150100-65045 |
Product
Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
Reason for recall
Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and if implanted the screws may not have adequate strength or performance.
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-0125-2025. 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.