Recall Z-1657-2025 · PGN Growing Rod System- Magnetic Actuation
Globus Medical, Inc.
MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
| Date | Apr 23, 2025 (initiated Apr 3, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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 Handlin |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution in the state of AR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171791 | MAGEC® System Nuvasive Specialized Orthopedics, Incorporated, Aug 31, 2017 |