# FDA recall Z-0117-2025

> **Spineology, Inc.** · Class II · device recall initiated 2024-09-16.

## 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 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.

## Distribution

Pending

## Key facts

- **Recall number:** Z-0117-2025
- **Recalling firm:** Spineology, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-16
- **Report date:** 2024-10-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0117-2025

## Citation

> AI Analytics. FDA recall Z-0117-2025. Retrieved 2026-08-03 from https://api.ai-analytics.org/recall/Z-0117-2025. Source: US FDA. Licensed CC0.

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