Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.
“NuVasive MAGEC 1 System Recall: Post-Implantation Fractures Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67600-nuvasive-magec-1-system-recall-post-implantation-fractures-risk. Based on FDA recall #Z-0528-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0528-2022%22&limit=1).
The FDA announced on June 25, 2019, that NuVasive Specialized Orthopedics, Inc. is recalling the MAGEC 1 System due to post-implantation fractures of an internal metallic component. The voluntary Class II recall affects 3,056 devices distributed worldwide.
How to tell if you have it
NuVasive MAGEC 1 System
All MAGEC Systems manufactured prior to March 26, 2015
The hazard
The recall addresses safety alerts regarding post-implantation fractures of an internal metallic component for devices manufactured prior to March 26, 2015. The record does not report specific incidents or injuries.
Context
NuVasive Specialized Orthopedics, Inc. has issued six other recalls since July 24, 2020, including the Sept. 30, 2024, recall of NuVasive Precice Max Orthopedic Devices for design and documentation issues. Other recent recalls of similar products include the Novapproach OneLIF Interbody Cage Recall (April 23, 2026), the GE Medical Systems Israel SMV BodyTrack Nuclear Medicine Systems Recall (Dec. 10, 2025), and the Howmedica SCORPIO Patella Implants Recall (July 30, 2026).
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.
How this recall unfolded
Recall timeline
FDA published this recall 2.6 years 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.
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.
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.