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.
Polyaxial screws do not meet performance standards.
Orthofix is recalling 25 specific sizes of polyaxial screws used in spinal fixation systems because they do not meet performance standards. This could lead to improper spinal fixation if used in medical procedures.
The polyaxial screws do not meet performance standards, which means they may not hold properly during spinal surgery. This could result in improper spinal fixation, potentially causing complications or failure of the surgical repair.
Patients and medical professionals who have received these specific screw sizes for spinal surgery are affected. Those using the recalled screws in procedures are at immediate risk of improper spinal fixation.
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.
Immediately stop using any of the 25 specific screw sizes listed in the recall notice if you have them for spinal surgery.
The recall includes 25 specific sizes: 5.5mm X 30mm to 50mm and 6.5mm X 30mm to 60mm, with corresponding item numbers and lot numbers.
Yes, if you have the recalled screws, contact Orthofix directly to confirm your specific model and lot numbers for proper handling.
Immediately stop using them and contact Orthofix to arrange for replacement or disposal as per their instructions.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-0478-2026 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-0478-2026 from Orthofix. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
