Stop using nowMedical device recall · FDA · Published September 19, 2025
Orthofix Virata Preassembled Polyaxial Screws: Do Not Use Due to Performance Issues
Orthofix recalls 25 specific sizes of Virata Preassembled Polyaxial Screws used in spinal fixation systems due to not meeting performance standards. Affected items include 5.5mm and 6.5mm screws with various lengths and lot numbers.
“Orthofix Virata Preassembled Polyaxial Screws: Do Not Use Due to Performance Issues.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51248-orthofix-virata-preassembled-polyaxial-screws-do-not-use-due-to. Based on FDA recall #Z-0478-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0478-2026%22&limit=1).
Orthofix U.S. LLC voluntarily recalled Virata Preassembled Polyaxial Screws used in the Virata Spinal Fixation System because they do not meet performance standards, the FDA said on Sept. 19, 2025.
The polyaxial screws do not meet performance standards, according to the FDA.
Context
GovInfoNow's records show Orthofix U.S. LLC has 4 other recalls on record since Feb. 20, 2025. Other recent recalls of similar products include Canon Alphenix X-ray Systems Recall (Aug. 4, 2026), Innovasis Anti-Torque Vector Pedicle Screw LS-749 Recall (May 22, 2026), and Canon Alphenix INFX-8000F X-Ray System Recall (Dec. 19, 2025).
How to tell if you have this one
Check if your spinal surgery kit includes any of the 25 specific screw sizes listed: 5.5mm or 6.5mm with lengths from 30mm to 60mm. Look for the item numbers and lot numbers provided in the recall notice.
Brand
Orthofix
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using Recalled Screws
Immediately stop using any of the 25 specific screw sizes listed in the recall notice if you have them for spinal surgery.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of California, North Carolina, and Texas.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, North Carolina, Texas.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0478-2026 (September 19, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0478-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.