Graft Tube (Spineology) – Shaft Detachment Risk (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Spineology, Inc.
Lot Codes / Batch Numbers
UDI-DI: M7403120056, Catalog Number: 312-0056, part Number: 33-09-14. Lot Numbers: CH20003, BE22003
Products Sold
UDI-DI: M7403120056, Catalog Number: 312-0056, part Number: 33-09-14. Lot Numbers: CH20003, BE22003
Spineology, Inc. is recalling The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft mater due to Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique.
Recommended Action
Per FDA guidance
Spineology began notification of medical institutions on 09/16/2024, direct sales representatives on 09/18/2024 and distributors on 09/19/2024 via letter. Instructions included to notify appropriate staff of the action and to complete and return the response form. Spineology will be performing a correction to update the surgical technique labeling and a removal will be conducted to replace current Graft Tubes within field inventory. Distributors were instructed to notify customers if further distributed.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026