Virata Preassembled Polyaxial Screw — Class II medical device recall Z-0478-2026
Ongoing recall by Orthofix U.S. LLC, reported 2025-11-19, distributed nationwide. Polyaxial screws do not meet performance standards.
| Recall number | Z-0478-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthofix U.S. LLC, Lewisville, TX, United States |
| Recall initiated | 2025-09-19 |
| Classified | 2025-11-07 |
| Reported by FDA | 2025-11-19 |
| Distributed | Nationwide (US) |
| Quantity | 624 units |
| UPC / GTIN / UDI-DI | 10889981334949, 10889981335076, 10889981335106, 10889981335113, 10889981335168, 10889981335229, 10889981335243, 10889981335250, 10889981335342, 10889981335403, 10889981335410, 10889981335427, 10889981335526, 10889981335540, 10889981335632, 10889981335717, 10889981335779, 10889981335816, 10889981335830, 10889981335847, 10889981335885, 10889981335953, 10889981336165, 10889981336318, 10889981336332 |
| Lot numbers | JP2572B, JP2655B, JP2656B, JP2657B, JP2658B, JP2659B, JP2660B, JP2661B, JP2662B, JP2663B, JP2664B, JP2665B, JP2666B, JP2667B, JP2668B, JP2669B, JP2670B, JP2671B, JP2672B, JP2673B, JP2674B, JP2675B, JP2757B, JP2758B, JP2759B, JP2760B, JP2791B, JP2792B, JP2794B, JP2795B, JP2799B, JP2800B, JP2801B, JP2880B, JP2887B |
| Model numbers | TL1-10755030, TL1-10755035, TL1-10755040, TL1-10755045, TL1-10755050, TL1-10765030, TL1-10765035, TL1-10765040, TL1-10765045, TL1-10765050, TL1-10765055, TL1-10765060, TL1-10775030, TL1-10775035, TL1-10775040, TL1-10775045, TL1-10775050, TL1-10775055, TL1-10775060, TL1-10785035, TL1-10785040, TL1-10785045, TL1-10785050, TL1-10785055, TL1-10785060 |
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 for recall
Polyaxial screws do not meet performance standards.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0478-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.