Saint Paul, MN, United States
Spineology, Inc. recalls
1 recall recorded since 2018, most recently on 16 September 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 16 September 2024
- 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.
- Distribution
- Pending
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0117-2025
- 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 m
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.