MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;

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.

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: [email protected] 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.