Recall Z-0117-2025— Spineology, Inc.
Class II · Ongoing
Class II FDA medical device recall by Spineology, Inc., initiated 2024-09-16. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique..
- Recalling firm
- Spineology, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-09-16
- Firm location
- Saint Paul, MN, United States
Product description
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.
Reason for recall
Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique.
Data sourced from openFDA. This site is unofficial and independent of the FDA.