NuVasive MAGEC 2 Rod Recall: Potential Sterile Packaging Failure
NuVasive recalls MAGEC 2 Rod spinal braces due to potential sterile packaging failure that could compromise device sterility during use.
Lower-risk recall
During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a potential of failure of the sterile packaging barrier which could result in a hazardous situation where the device is no longer sterile.
Contact the company
What happened, in plain English
NuVasive is recalling MAGEC 2 Rod spinal braces because the sterile packaging might fail during storage, risking contamination of the device. This could lead to infection or other complications if the device is used without proper sterility. Read more at govinfonow.com/recall/59788-nuvasive-magec-2-rod-recall-potential-sterile-packaging-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/59788-nuvasive-magec-2-rod-recall-potential-sterile-packaging-failure · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0559-2023
Cite this page
“NuVasive MAGEC 2 Rod Recall: Potential Sterile Packaging Failure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59788-nuvasive-magec-2-rod-recall-potential-sterile-packaging-failure. Based on FDA recall #Z-0559-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0559-2023%22&limit=1).
Why it’s dangerous
The sterile packaging for these spinal braces could potentially fail during shelf-life extension studies, meaning the device might not remain sterile when used. This could lead to infection or other complications if the device is not properly sterilized before implantation.
Who’s affected
Patients with spinal braces made by NuVasive using the MAGEC 2 Rod system. The risk is low for most users as the packaging failure would need to occur during storage before use.
How to tell if you have this one
Check for model numbers like MC2-4590S, MC2-5590S, MC2-6090R, etc. with specific lot numbers listed in the recall notice. The product is used for spinal bracing during growth to minimize scoliosis progression.
- Brand
NuVasive- Category
Medical device
What to do — step by step
Check Product Details
Identify your MAGEC 2 Rod model and lot numbers from the list provided in the recall notice.
Contact Manufacturer
Reach out to NuVasive Specialized Orthopedics, Inc. for guidance on next steps if you have the recalled product.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Distribution US nationwide including Puerto Rico; Chile, Israel, Jordan, New Zealand, Singapore, Sweden, Thailand, and United Arab Emirates.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 50 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0559-2023 (November 1, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0559-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.