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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Globus Medical MAGEC 2 Rod System Recalled for Incorrect Diameter

Agency Publication Date: April 23, 2025
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Summary

Globus Medical, Inc. has recalled one unit of the MAGEC 2 Rod (5.0mm 90mm Standard), model MC2-5090S. The device was incorrectly assembled with a 5.5mm distraction rod diameter instead of the required 5.0mm specification. No injuries or incidents have been reported, but the assembly error was identified during quality control processes.

Risk

The incorrect diameter of the surgical rod may result in the device being incompatible with intended surgical tools or anatomical requirements, potentially leading to surgical delays or device failure. No injuries have been reported.

What You Should Do

  1. This recall affects one unit of the MAGEC 2 Rod, 5.0mm 90mm Standard (Model MC2-5090S), identified by lot number GB1607ET and UDI-DI 00887517834041.
  2. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  3. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding medical device recalls.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: MAGEC 2 Rod, 5.0mm 90mm Standard
Variants: 5.0mm 90mm Standard
Model / REF:
MC2-5090S
Lot Numbers:
GB1607ET
UDI:
00887517834041

Quantity: 1 unit affected.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96615
Status: Active
Manufacturer: Globus Medical, Inc.
Sold By: Globus Medical, Inc.
Manufactured In: United States
Units Affected: 1 unit
Distributed To: Arkansas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.