Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected: 1.
FDA device recall Z-0478-2026 · posted 2025-11-07 · Open, Classified
Recall details
- Recalling firm
- Orthofix U.S. LLC
- Reason for recall
- Polyaxial screws do not meet performance standards.
- Action taken
- Orthofix notified consignees via email on 09/19/2025. Consignees were instructed to immediately discontinue use of the affected devices, quarantine all affected inventory, and return units to Orthofix using the provided Return Goods Authorization (RGA) process. Surgeons were instructed to monitor affected patients according to standard clinical practice. Customers were advised not to implant or distribute any remaining affected product. All consignees were requested to complete and return the response form.
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- NKB
- Quantity affected
- 624 units
- Distribution
- US Nationwide distribution in the states of California, North Carolina, and Texas.
- Date initiated
- 2025-09-19
- Date posted
- 2025-11-07
- Location
- Lewisville, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Virata Spinal Fixation System (K250908) | SeaSpine Orthopedics Corporation | 2025-06-18 |