Recall Z-0478-2026 ยท NKB Thoracolumbosacral Pedicle Screw System
Orthofix U.S. LLC
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 SCR
| Date | Nov 7, 2025 (initiated Sep 19, 2025) |
| Status | Open, Classified |
| Reason | Polyaxial screws do not meet performance standards. |
| Root cause | Process change control |
| Action | 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. |
| Quantity | 624 units |
| Distribution | US Nationwide distribution in the states of California, North Carolina, and Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K250908 | Virata Spinal Fixation System SeaSpine Orthopedics Corporation, Jun 18, 2025 |