NuVasive recalls MAGEC 2 Rod spinal braces due to potential sterile packaging failure that could compromise device sterility during use.
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.
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.
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.
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.
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.
Identify your MAGEC 2 Rod model and lot numbers from the list provided in the recall notice.
Reach out to NuVasive Specialized Orthopedics, Inc. for guidance on next steps if you have the recalled product.
The recall is due to potential failure of the sterile packaging during shelf-life extension studies, which could compromise device sterility.
The risk is low as the packaging failure would need to occur before use, but it could lead to infection or complications if the device is not properly sterile.
Check for model numbers like MC2-4590S, MC2-5590S, MC2-6090R, etc. with specific lot numbers listed in the recall notice.
We’ve drafted a message you can send NuVasive to request your refund or repair — edit it as you like.
Subject: Recall Z-0559-2023 — NuVasive NuVasive Hello, I own a NuVasive that is covered by recall Z-0559-2023 from NuVasive. 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.
