| | Class 2 Device Recall VIRATA" PREASSEMBLED POLYAXIAL SCREWS |  |
| Date Initiated by Firm | September 19, 2025 |
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| Date Posted | November 07, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0478-2026 |
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| Recall Event ID |
97689 |
| 510(K)Number | K250908 |
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| Product Classification |
Thoracolumbosacral pedicle screw system - Product Code NKB
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| 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. |
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| Code Information |
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.
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Recalling Firm/
Manufacturer |
Orthofix U.S. LLC
3451 Plano Pkwy
Lewisville TX 75056-9453
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| For Additional Information Contact | SeaSpine Complaints
214-937-2000 |
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Manufacturer Reason
for Recall | Polyaxial screws do not meet performance standards. |
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FDA Determined
Cause 2 | Process change control |
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| 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. |
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| Quantity in Commerce | 624 units |
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| Distribution | US Nationwide distribution in the states of California, North Carolina, and Texas. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = NKB
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