MAGEC 1 System
Class I - DangerousWhat Should You Do?
- Check if you have this product: All MAGEC Systems (Serial/Lot Numbers) manufactured prior to March 26, 2015.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- NuVasive Specialized Orthopedics, Inc.
- Reason for Recall:
- Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
MAGEC 1 System
Product Codes/Lot Numbers:
All MAGEC Systems (Serial/Lot Numbers) manufactured prior to March 26, 2015.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0528-2022
Related Recalls
Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.
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.
The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no more than two devices should be implanted at a time.