NuVasive MAGEC 1 System Recall: Post-Implantation Fractures Risk

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Contact the company & request your remedy

Recalling firmNuVasive Specialized Orthopedics, Inc.101 Enterprise Ste 100 · Aliso Viejo, CA 92656-2604

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

NuVasive is recalling MAGEC 1 spinal implants made before March 26, 2015 because they can fracture internally after surgery. This could lead to complications requiring additional procedures.

Why it’s dangerous

The internal metallic component of the implant can fracture after surgery. This may require additional procedures to address the fracture and prevent complications.

Who’s affected

Surgeons who implanted MAGEC 1 systems before March 26, 2015. Patients who received these implants are at risk of internal fractures.

How to tell if you have this one

Check if your MAGEC 1 System was manufactured before March 26, 2015. The recall covers all units with serial/lot numbers from that date onward.

Brand
NuVasive
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Date
Verify your implant's manufacturing date to confirm if it was made before March 26, 2015.

✎ GovInfoNow

Questions people ask

Do I need to do anything if my implant was made after March 26, 2015?

The recall only applies to implants manufactured before March 26, 2015. After that date, no action is needed.

What should I do if I had this implant?

Contact NuVasive directly to discuss your specific case and potential next steps.

Is there a risk of serious injury from this implant?

The recall states a risk of post-implantation fractures, which may require additional procedures. Serious injury is not explicitly mentioned in the hazard description.

Take action

Contact NuVasive

We’ve drafted a message you can send NuVasive to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0528-2022 — NuVasive NuVasive

Hello,

I own a NuVasive that is covered by recall Z-0528-2022 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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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-0528-2022 (June 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0528-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.

NuVasive Specialized Orthopedics, Inc. recalls MAGEC 1 System

Lower-risk recall