MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
This recall is currently active, issued April 23, 2025. It was issued by Globus Medical, Inc..
- Company
- Globus Medical, Inc.
- Recall Initiated
- April 3, 2025
- Posted
- April 23, 2025
- Recall Number
- Z-1657-2025
- Quantity
- 1 unit
- Firm Location
- West Norriton, PA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Nationwide distribution in the state of AR.
Lot / Code Info
Version/Model: MC2-5090S; UDI-DI (with lot nuber): (01)00887517834041(11)250311(17)300311(10)GB1607ET
Root Cause
Nonconforming Material/Component
Action Taken
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.