Orthofix U.S. LLC: 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

Hazard

Polyaxial screws do not meet performance standards.

Details from the source

Reason for recall: Polyaxial screws do not meet performance standards. Distribution: US Nationwide distribution in the states of California, North Carolina, and Texas. Quantity: 624 units 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

UPC codes

10889981335229, 10889981336165, 10889981335717, 10889981335953, 10889981336318, 10889981335885, 10889981335540, 10889981336332, 10889981335526, 10889981335342, 10889981335168, 10889981335816, 10889981335427, 10889981335632, 10889981335113, 10889981335403, 10889981335830, 10889981335250, 10889981335076, 10889981335410, 10889981335779, 10889981335243, 10889981335847, 10889981335106, 10889981334949

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.