MAGEC 2 Rod (Globus Medical) – Incorrect Rod Diameter (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Brand
Globus Medical, Inc.
Lot Codes / Batch Numbers
Version/Model: MC2-5090S, UDI-DI (with lot nuber): (01)00887517834041(11)250311(17)300311(10)GB1607ET
Products Sold
Version/Model: MC2-5090S; UDI-DI (with lot nuber): (01)00887517834041(11)250311(17)300311(10)GB1607ET
Globus Medical, Inc. is recalling MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S; due to Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm ro. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm.
Recommended Action
Per FDA guidance
On April 3, 2025, URGENT: MEDICAL DEVICE NOTIFICATION letter was sent to their customer. Actions to be taken by Customers/Users The customer is instructed to monitor their patient closely for any potential adverse events. Report any adverse events believed to be associated with this notification to Globus Medical. In addition, any adverse events associated with the use of this product and/or quality problems should also be reported to the FDA's MedWatch Program: MedWatch: The FDA Safety Information and Adverse Event Reporting Program; For Questions and Support: Globus Medical Complaint Handling Unit: Email: recall@globusmedical.com Globus Medical is committed to serving your product needs and our primary objectives are patient safety, exceptional product reliability, and the highest level of customer satisfaction. Thank you for your prompt support on this important matter. We appreciate your cooperation.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026