Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected:
Summary
The FDA issued a Class II for Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation Syst by Orthofix U.S. LLC. Reason: Polyaxial screws do not meet performance standards..
Details
Source
Device Recall
External ID
Z-0478-2026
Action Date
2025-11-19
Status
Ongoing
Category
device
Product 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.
Lot/Code Info: 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.
Quantity Affected: 624 units
Reason for Recall
Polyaxial screws do not meet performance standards.
Distribution
US Nationwide distribution in the states of California, North Carolina, and Texas.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-19
Company
Lewisville, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 148 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Orthofix U.S. LLC has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Orthofix U.S. LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Orthofix U.S. LLC have FDA actions?
Orthofix U.S. LLC has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0478-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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