Class II — Spineology, Inc.
| Recalling firm | Spineology Inc |
|---|---|
| Registered facility | SPINEOLOGY INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| 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. |
| Quantity | 190 units |
| Distribution | Pending |
| Initiated | 2024-09-16 |
| Classified | 2024-10-17 |
| Recall number | Z-0117-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Spineology, Inc. (Z-0117-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95341/
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