The Graft Tube is an optional instrument which — Class II medical device recall Z-0117-2025
Ongoing recall by Spineology, Inc., reported 2024-10-23. Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed
| Recall number | Z-0117-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spineology, Inc., Saint Paul, MN, United States |
| Recall initiated | 2024-09-16 |
| Classified | 2024-10-17 |
| Reported by FDA | 2024-10-23 |
| Quantity | 190 units |
| Reason classes | device malfunction |
| Lot numbers | BE22003, CH20003 |
| Model numbers | 312-0056, 33-09-14 |
Product
The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced through the Access Portal. A Push Rod is then used to facilitate the manual deployment of the graft material out of the Graft Tube and adjacent to where the implant is to be placed, as supported within the Surgical Technique Guide.
Reason for recall
Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique.
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-0117-2025. 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.