Spineology, Inc. recalls The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced t

Recalled October 23, 2024 · FDA recall Z-0117-2025 · Spineology

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. · FDA Class II

Units

190 units

Sold at

Pending

Description

Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique.

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.

Manufacturer(s)

Spineology, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →