BEUDAMED
    FDA Recall Open, Classified

    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: TL1-10775030. 14. POLYAXIAL SCREW, CC, 7.5mm X 35mm; Item Number: TL1-10775035. 15. POLYAXIAL SCREW, CC, 7.5mm X 40mm; Item Number: TL1-10775040. 16. POLYAXIAL SCREW, CC, 7.5mm X 45mm; Item Number: TL1-10775045. 17. POLYAXIAL SCREW, CC, 7.5mm X 50mm; Item Number: TL1-10775050. 18. POLYAXIAL SCREW, CC, 7.5mm X 55mm; Item Number: TL1-10775055. 19. POLYAXIAL SCREW, CC, 7.5mm X 60mm; Item Number: TL1-10775060. 20. POLYAXIAL SCREW, CC, 8.5mm X 35mm; Item Number: TL1-10785035. 21. POLYAXIAL SCREW, CC, 8.5mm X 40mm; Item Number: TL1-10785040. 22. POLYAXIAL SCREW, CC, 8.5mm X 45mm; Item Number: TL1-10785045. 23. POLYAXIAL SCREW, CC, 8.5mm X 50mm; Item Number: TL1-10785050. 24. POLYAXIAL SCREW, CC, 8.5mm X 55mm; Item Number: TL1-10785055. 25. POLYAXIAL SCREW, CC, 8.5mm X 60mm; Item Number: TL1-10785060.

    Recall: Z-0478-2026 · Initiated September 19, 2025

    Recall

    Recall Number
    Z-0478-2026
    Event Number
    97689
    Firm
    Orthofix U.S. LLC
    FEI Number
    2183449
    Product Code
    NKB
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    September 19, 2025
    Posted
    November 7, 2025
    Address
    3451 Plano Pkwy, Lewisville, TX, 75056-9453

    Description

    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: TL1-10775030. 14. POLYAXIAL SCREW, CC, 7.5mm X 35mm; Item Number: TL1-10775035. 15. POLYAXIAL SCREW, CC, 7.5mm X 40mm; Item Number: TL1-10775040. 16. POLYAXIAL SCREW, CC, 7.5mm X 45mm; Item Number: TL1-10775045. 17. POLYAXIAL SCREW, CC, 7.5mm X 50mm; Item Number: TL1-10775050. 18. POLYAXIAL SCREW, CC, 7.5mm X 55mm; Item Number: TL1-10775055. 19. POLYAXIAL SCREW, CC, 7.5mm X 60mm; Item Number: TL1-10775060. 20. POLYAXIAL SCREW, CC, 8.5mm X 35mm; Item Number: TL1-10785035. 21. POLYAXIAL SCREW, CC, 8.5mm X 40mm; Item Number: TL1-10785040. 22. POLYAXIAL SCREW, CC, 8.5mm X 45mm; Item Number: TL1-10785045. 23. POLYAXIAL SCREW, CC, 8.5mm X 50mm; Item Number: TL1-10785050. 24. POLYAXIAL SCREW, CC, 8.5mm X 55mm; Item Number: TL1-10785055. 25. POLYAXIAL SCREW, CC, 8.5mm X 60mm; Item Number: TL1-10785060.

    Reason

    Polyaxial screws do not meet performance standards.

    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.

    Distribution

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

    Quantity

    624 units