# FDA recall Z-1432-2025

> **Orthofix U.S. LLC** · Class II · device recall initiated 2025-02-20.

## Product

Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy:    (1) REF 82-3300SP, 33mm W x 24mm D x 10mm H, 7 degrees;  (2) REF 82-3700SP, 37mm W x 28mm D x 10mm H, 7 degrees; and  (3) REF 82-4000SP, 40mm W x 32mm D x 10mm H, 7 degrees.

## Reason for recall

The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.

## Distribution

US Nationwide distribution in the states of California, Colorado, and Missouri.

## Key facts

- **Recall number:** Z-1432-2025
- **Recalling firm:** Orthofix U.S. LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-20
- **Report date:** 2025-04-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lewisville, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1432-2025

## Citation

> AI Analytics. FDA recall Z-1432-2025. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-1432-2025. Source: US FDA. Licensed CC0.

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