FDAFDA · Food and drugs·Recall number Z-0117-2025
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.
Published October 23, 2024 · Recall initiated: September 16, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Spineology, Inc.
- Distributor
- Pending
- Lot
- UDI-DI: M7403120056, Catalog Number: 312-0056, part Number: 33-09-14. Lot Numbers: CH20003, BE22003
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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