# FDA recall Z-0478-2026

> **Orthofix U.S. LLC** · Class II · device recall initiated 2025-09-19.

## Product

Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected:     1. POLYAXIAL SCREW, CC, 5.5mm X 30mm; Item Number: TL1-10755030.    2. POLYAXIAL SCREW, CC, 5.5mm X 35mm; Item Number: TL1-10755035.    3. POLYAXIAL SCREW, CC, 5.5mm X 40mm; Item Number: TL1-10755040.    4. POLYAXIAL SCREW, CC, 5.5mm X 45mm; Item Number: TL1-10755045.    5. POLYAXIAL SCREW, CC, 5.5mm X 50mm; Item Number: TL1-10755050.    6. POLYAXIAL SCREW, CC, 6.5mm X 30mm; Item Number: TL1-10765030.    7. POLYAXIAL SCREW, CC, 6.5mm X 35mm; Item Number: TL1-10765035.    8. POLYAXIAL SCREW, CC, 6.5mm X 40mm; Item Number: TL1-10765040.    9. POLYAXIAL SCREW, CC, 6.5mm X 45mm; Item Number: TL1-10765045.    10. POLYAXIAL SCREW, CC, 6.5mm X 50mm; Item Number: TL1-10765050.    11. POLYAXIAL SCREW, CC, 6.5mm X 55mm; Item Number: TL1-10765055.    12. POLYAXIAL SCREW, CC, 6.5mm X 60mm; Item Number: TL1-10765060.    13. POLYAXIAL SCREW, CC, 7.5mm X 30mm; Item Number: TL1-107

## Reason for recall

Polyaxial screws do not meet performance standards.

## Distribution

US Nationwide distribution in the states of California, North Carolina, and Texas.

## Key facts

- **Recall number:** Z-0478-2026
- **Recalling firm:** Orthofix U.S. LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-19
- **Report date:** 2025-11-19

- **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-0478-2026

## Citation

> AI Analytics. FDA recall Z-0478-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0478-2026. Source: US FDA. Licensed CC0.

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