# FDA recall Z-1177-2025

> **XTANT Medical Holdings, Inc** · Class II · device recall initiated 2025-01-03.

## Product

Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) and Model Number X080-382819-08PC (Spacer ASSY, 38 X 28 X 8¿, 19mm, PC, (STERILE))

## Reason for recall

Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.

## Distribution

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, LA, OH, TX, and WV. The country of Australia.

## Key facts

- **Recall number:** Z-1177-2025
- **Recalling firm:** XTANT Medical Holdings, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-03
- **Report date:** 2025-02-26

- **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-1177-2025

## Citation

> AI Analytics. FDA recall Z-1177-2025. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-1177-2025. Source: US FDA. Licensed CC0.

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