Class II U.S. Food and Drug Administration

Orthofix U.S. LLC Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal recall: Polyaxial screws do not meet performance standards

Recall published 11 months ago

Polyaxial screws do not meet performance standards.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Polyaxial screws do not meet performance standards.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0478-2026
Published
November 19, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Orthofix U.S. LLC
Product type
Medical devices
Units affected
624 units
Distribution
Nationwide
Made in
United States
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.

Products covered by this recall

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.

Check your product

The notice names 31 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • JP2759B
  • JP2799B
  • JP2800B
  • JP2760B
  • JP2657B
  • JP2658B
  • JP2659B
  • JP2660B
  • JP2794B
  • JP2672B
  • JP2667B. — 624 units

Model or item number

On the rating label, the box or the instruction sheet.

  • TL1-10755030. 2. POLYAXIAL SCREW
  • CC
  • 5.5mm X 35mm
  • TL1-10755035. 3. POLYAXIAL SCREW
  • 5.5mm X 40mm
  • TL1-10755040. 4. POLYAXIAL SCREW
  • 5.5mm X 45mm
  • TL1-10755045. 5. POLYAXIAL SCREW
  • 5.5mm X 50mm
  • TL1-10755050. 6. POLYAXIAL SCREW
  • 6.5mm X 30mm
  • TL1-10765030. 7. POLYAXIAL SCREW
  • 6.5mm X 35mm
  • TL1-10765035. 8. POLYAXIAL SCREW
  • 6.5mm X 40mm
  • TL1-10765040. 9. POLYAXIAL SCREW
  • 6.5mm X 45mm
  • TL1-10765045. 10. POLYAXIAL SCREW
  • 6.5mm X 50mm
  • TL1-10765050. 11. POLYAXIAL SCREW

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Orthofix U.S. LLC — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Orthofix U.S. LLC — 3451 Plano Pkwy, Lewisville, TX, 75056-9453

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Orthofix U.S. LLC medical devices recalled?

Polyaxial screws do not meet performance standards. Polyaxial screws do not meet performance standards.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code JP2759B, JP2799B, JP2800B; model number TL1-10755030. 2. POLYAXIAL SCREW, CC, 5.5mm X 35mm. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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