# FDA recall Z-2555-2025

> **Orthofix U.S. LLC** · Class II · device recall initiated 2025-06-24.

## Product

PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP

## Reason for recall

A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct.

## Distribution

US Nationwide distribution in the states of CO, CA.

## Key facts

- **Recall number:** Z-2555-2025
- **Recalling firm:** Orthofix U.S. LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-24
- **Report date:** 2025-09-17

- **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-2555-2025

## Citation

> AI Analytics. FDA recall Z-2555-2025. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-2555-2025. Source: US FDA. Licensed CC0.

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