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

Recall date

September 16, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0117-2025

FDA classification

Class II

Brand / firm

Spineology, Inc.

Sold / distributed

Pending

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.