CLASS II ONGOING Device recall · Reported 19 Nov 2025 · FDA Enforcement Report

Virata Preassembled Polyaxial Screw, utilized recalled by Orthofix U.S

Orthofix U.S is recalling Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System, distributed nationwide in the US. The recall was initiated on 19 Sep 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1. 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 recalled624 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0478-2026
FDA event ID: 97689
Recalling firm: Orthofix U.S, Lewisville, TX
Classification: Class II
Status: Ongoing
Recall initiated: 19 Sep 2025
FDA classified: 7 Nov 2025
Reported: 19 Nov 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

19 Sep 2025	Recall initiated by company
7 Nov 2025	Classified by FDA	+49 days
19 Nov 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Polyaxial screws do not meet performance standards.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide distribution in the states of California, North Carolina, and Texas.

Nationwide California North Carolina Texas

Questions about this recall

Why was it recalled?

Polyaxial screws do not meet performance standards.

Which lots are affected?

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.

Where was it sold?

US Nationwide distribution in the states of California, North Carolina, and Texas.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Orthofix U.S

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Reported	Class	Recall	Company	Reason	Where
22 Jul 2026Device	CLASS II	Orthofix Minirail, Short, Lengthener recalled by Orthofix U.S	Orthofix U.S	Labeling Errors	22 states
22 Jul 2026Device	CLASS II	Orthofix Minirail, Articulated, Fixator, Vertical Axis recalled	Orthofix U.S	Labeling Errors	22 states
22 Jul 2026Device	CLASS II	Orthofix Articulated Minirail Fixator Horizontal Axis recalled	Orthofix U.S	Labeling Errors	22 states
22 Jul 2026Device	CLASS II	Orthofix Minirail, Standard Lengthener recalled by Orthofix U.S	Orthofix U.S	Labeling Errors	22 states
17 Dec 2025Device	CLASS III	Forza" PTC Spacer System recalled by Orthofix U.S	Orthofix U.S	Other	Nationwide

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