Spineology, Inc. recalls The Graft Tube is an optional instrument which, as designed,
Recalled 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.
Hazard / Issue
Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique.
Issued by
FDA
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