Reported Nov 19, 2025 · Ongoing
Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected:…
Orthofix U.S. LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Orthofix U.S. LLC · 3451 Plano Pkwy · Lewisville, TX · 75056-9453
Is this the product you have?
Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected
25 of 25 products
| Model / number | Product as published |
|---|---|
TL1-10755030. | POLYAXIAL SCREW, CC, 5.5mm X 30mm |
TL1-10755035. | POLYAXIAL SCREW, CC, 5.5mm X 35mm |
TL1-10755040. | POLYAXIAL SCREW, CC, 5.5mm X 40mm |
TL1-10755045. | POLYAXIAL SCREW, CC, 5.5mm X 45mm |
TL1-10755050. | POLYAXIAL SCREW, CC, 5.5mm X 50mm |
TL1-10765030. | POLYAXIAL SCREW, CC, 6.5mm X 30mm |
TL1-10765035. | POLYAXIAL SCREW, CC, 6.5mm X 35mm |
TL1-10765040. | POLYAXIAL SCREW, CC, 6.5mm X 40mm |
TL1-10765045. | POLYAXIAL SCREW, CC, 6.5mm X 45mm |
TL1-10765050. | POLYAXIAL SCREW, CC, 6.5mm X 50mm |
TL1-10765055. | POLYAXIAL SCREW, CC, 6.5mm X 55mm |
TL1-10765060. | POLYAXIAL SCREW, CC, 6.5mm X 60mm |
TL1-10775030. | POLYAXIAL SCREW, CC, 7.5mm X 30mm |
TL1-10775035. | POLYAXIAL SCREW, CC, 7.5mm X 35mm |
TL1-10775040. | POLYAXIAL SCREW, CC, 7.5mm X 40mm |
TL1-10775045. | POLYAXIAL SCREW, CC, 7.5mm X 45mm |
TL1-10775050. | POLYAXIAL SCREW, CC, 7.5mm X 50mm |
TL1-10775055. | POLYAXIAL SCREW, CC, 7.5mm X 55mm |
TL1-10775060. | POLYAXIAL SCREW, CC, 7.5mm X 60mm |
TL1-10785035. | POLYAXIAL SCREW, CC, 8.5mm X 35mm |
- Amount recalled
- 624 units
Where it was sold
Why it was recalled
Polyaxial screws do not meet performance standards.
This product could cause temporary or reversible health problems — stop using it.
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