# FDA recall Z-0125-2025

> **XTANT Medical Holdings, Inc** · Class II · device recall initiated 2024-08-21.

## Product

Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045

## Reason for recall

Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and if implanted the screws may not have adequate strength or performance.

## Distribution

US Nationwide distribution in the states of IL, WI, FL, PA, CA, TX, MI, MO, VA, OH, MA.

## Key facts

- **Recall number:** Z-0125-2025
- **Recalling firm:** XTANT Medical Holdings, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-21
- **Report date:** 2024-10-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Belgrade, MT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0125-2025

## Citation

> AI Analytics. FDA recall Z-0125-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0125-2025. Source: US FDA. Licensed CC0.

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