Orthofix U.S. LLC recalls Virata Preassembled Polyaxial Screw
Reason for recall
Polyaxial screws do not meet performance standards.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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 information
- Part / Item #
- TL1-10755030
- UDI
- 10889981335229
- Lot #
- JP2572B. 2
- Part / Item #
- TL1-10755035
- UDI
- 10889981336165
- Lot #
- JP2757B. 3
- Part / Item #
- TL1-10755040
- UDI
- 10889981335717
- Lot #
- JP2758B. 4
- Part / Item #
- TL1-10755045
- UDI
- 10889981335953
- Lot #
- JP2759B, JP2799B, JP2800B, JP2880B. 5
- Part / Item #
- TL1-10755050
- UDI
- 10889981336318
- Lot #
- JP2760B, JP2801B. 6
- Part / Item #
- TL1-10765030
- UDI
- 10889981335885
- Lot #
- JP2655B. 7
- Part / Item #
- TL1-10765035
- UDI
- 10889981335540
- Lot #
- JP2656B. 8
- Part / Item #
- TL1-10765040
- UDI
- 10889981336332
- Lot #
- JP2657B, JP2791B. 9
- Part / Item #
- TL1-10765045
- UDI
- 10889981335526
- Lot #
- JP2658B, JP2659B, JP2792B. 10
- Part / Item #
- TL1-10765050
- UDI
- 10889981335342
- Lot #
- JP2660B, JP2794B, JP2795B. 11
- Part / Item #
- TL1-10765055
- UDI
- 10889981335168
- Lot #
- JP2661B. 12
- Part / Item #
- TL1-10765060
- UDI
- 10889981335816
- Lot #
- JP2662B. 13
- Part / Item #
- TL1-10775030
- UDI
- 10889981335427
- Lot #
- JP2663B. 14
- Part / Item #
- TL1-10775035
- UDI
- 10889981335632
- Lot #
- JP2668B. 15
- Part / Item #
- TL1-10775040
- UDI
- 10889981335113
- Lot #
- JP2669B. 16
- Part / Item #
- TL1-10775045
- UDI
- 10889981335403
- Lot #
- JP2670B. 17
- Part / Item #
- TL1-10775050
- UDI
- 10889981335830
- Lot #
- JP2671B. 18
- Part / Item #
- TL1-10775055
- UDI
- 10889981335250
- Lot #
- JP2672B, JP2887B. 19
- Part / Item #
- TL1-10775060
- UDI
- 10889981335076
- Lot #
- JP2673B. 20
- Part / Item #
- TL1-10785035
- UDI
- 10889981335410
- Lot #
- JP2674B. 21
- Part / Item #
- TL1-10785040
- UDI
- 10889981335779
- Lot #
- JP2675B. 22
- Part / Item #
- TL1-10785045
- UDI
- 10889981335243
- Lot #
- JP2664B. 23
- Part / Item #
- TL1-10785050
- UDI
- 10889981335847
- Lot #
- JP2665B. 24
- Part / Item #
- TL1-10785055
- UDI
- 10889981335106
- Lot #
- JP2666B. 25
- Part / Item #
- TL1-10785060
- UDI
- 10889981334949
- Lot #
- JP2667B
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What the firm is doing
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.
DistributionShow detailsHide
US Nationwide distribution in the states of California, North Carolina, and Texas.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0478-2026
- FDA 510(k) clearance · K250908The device's official FDA premarket clearance record
- FDA device classification · NKBOfficial FDA classification for this device type
- CFR regulation · 21 CFR 888.3070The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Orthofix U.S. LLCSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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