FDA Device recall Z-0478-2026
Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System
- FDA Device
- Class II
- ongoing
- Published 2025-11-19
On 2025-11-19 the FDA classified a Class II recall of Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System by Orthofix U S, citing polyaxial screws do not meet performance standards.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0478-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-19 |
| Published | 2025-11-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Orthofix U S |
| Distribution | US |
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: TL1-10775030. 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.
Identifiers
| code_info | 1. Item Number: TL1-10755030. UDI-DI: 10889981335229. Lot Number: JP2572B. 2. Item Number: TL1-10755035. UDI-DI: 10889…1. Item Number: TL1-10755030. UDI-DI: 10889981335229. Lot Number: JP2572B. 2. Item Number: TL1-10755035. UDI-DI: 10889981336165. Lot Number: JP2757B. 3. Item Number: TL1-10755040. UDI-DI: 10889981335717. Lot Number: JP2758B. 4. Item Number: TL1-10755045. UDI-DI: 10889981335953. Lot Numbers: JP2759B, JP2799B, JP2800B, JP2880B. 5. Item Number: TL1-10755050. UDI-DI: 10889981336318. Lot Numbers: JP2760B, JP2801B. 6. Item Number: TL1-10765030. UDI-DI: 10889981335885. Lot Number: JP2655B. 7. Item Number: TL1-10765035. UDI-DI: 10889981335540. Lot Number: JP2656B. 8. Item Number: TL1-10765040. UDI-DI: 10889981336332. Lot Number: JP2657B, JP2791B. 9. Item Number: TL1-10765045. UDI-DI: 10889981335526. Lot Numbers: JP2658B, JP2659B, JP2792B. 10. Item Number: TL1-10765050. UDI-DI: 10889981335342. Lot Numbers: JP2660B, JP2794B, JP2795B. 11. Item Number: TL1-10765055. UDI-DI: 10889981335168. Lot Number: JP2661B. 12. Item Number: . UDI-DI: . Lot Number: Item Number: TL1-10765060. UDI-DI: 1 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0478-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.