Recall archive / FDA device enforcement
The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advance... — FDA record Z-0117-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 16, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique.
- Classification
- Class II
- Recalling firm
- Spineology, Inc.
- Quantity
- 190 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0117-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: M7403120056, Catalog Number: 312-0056, part Number: 33-09-14. Lot Numbers: CH20003, BE22003 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Pending
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Oct 23, 2024
- Recall initiation date
- Sep 16, 2024
- Center classification date
- Oct 17, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.