Recall archive / FDA device enforcement
Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected:... — FDA record Z-0478-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 19, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Orthofix U.S. LLC
- Quantity
- 624 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0478-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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: 10889981335816. Lot Number: JP2662B. 13. Item Number: TL1-10775030. UDI-DI: 10889981335427. Lot Number: JP2663B. 14. Item Number: TL1-10775035. UDI-DI: 10889981335632. Lot Number: JP2668B. 15. Item Number: TL1-10775040. UDI-DI: 10889981335113. Lot Number: JP2669B. 16. Item Number: TL1-10775045. UDI-DI: 10889981335403. Lot Number: JP2670B. 17. Item Number: TL1-10775050. UDI-DI: 10889981335830. Lot Number: JP2671B. 18. Item Number: TL1-10775055. UDI-DI: 10889981335250. Lot Numbers: JP2672B, JP2887B. 19. Item Number: TL1-10775060. UDI-DI: 10889981335076. Lot Number: JP2673B. 20. Item Number: TL1-10785035. UDI-DI: 10889981335410. Lot Number: JP2674B. 21. Item Number: TL1-10785040. UDI-DI: 10889981335779. Lot Number: JP2675B. 22. Item Number: TL1-10785045. UDI-DI: 10889981335243. Lot Number: JP2664B. 23. Item Number: TL1-10785050. UDI-DI: 10889981335847. Lot Number: JP2665B. 24. Item Number: TL1-10785055. UDI-DI: 10889981335106. Lot Number: JP2666B. 25. Item Number: TL1-10785060. UDI-DI: 10889981334949. Lot Number: JP2667B. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of California, North Carolina, and Texas.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Nov 19, 2025
- Recall initiation date
- Sep 19, 2025
- Center classification date
- Nov 7, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.