Spineology, Inc.: Device Recall
Recall #Z-0117-2025 · 09/16/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0117-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Spineology, Inc.
- Status
- Ongoing
- Date Initiated
- 09/16/2024
- Location
- Saint Paul, MN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 190 units
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.
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.
Distribution Pattern
Pending
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.