NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of scoliosis. REF Model Numbers/NSO Item #/Product Description MC2-4590S / PA0684-001 / MAGEC 2 Rod, 4.5mm 90mm Standard MC2-5590S / PA0684-002 / MAGEC 2 Rod, 5.5,mm 90mm Standard MC2-6090R / PA0684-003 / MAGEC 2 Rod, 6.0mm 70mm Offset MC2-4590R / PA0684-004 / MAGEC 2 Rod, 4.5mm 90mm Offset MC2-5590R / PA0684-005 / MAGEC 2 Rod, 5.5mm 90mm Offset MC2-6090S / PA0684-006 / MAGEC 2 Rod, 6.0mm 70mm Standard MC2-4570S / PA0684-007 / MAGEC 2 Rod, 4.5mm 70mm Standard MC2-5570S / PA0684-008 / MAGEC 2 Rod, 5.5mm 70mm Standard MC2-6070S / PA0684-009 / MAGEC 2 Rod, 6.0mm 70mm Standard MC2-4570R / PA0684-010 / MAGEC 2 Rod, 4.5mm 70mm Offset MC2-5570R / PA0684-011 / MAGEC 2 Rod, 5.5mm 70mm Offset MC2-6070R / PA0864-012 / MAGEC 2 Rod, 6.0mm 70mm Offset MC2-5090S / PA0684-013 / MAGEC 2 Rod, 5.0mm 90mm Standard MC2-5090R / PA0684-014 / MAGEC 2 Rod, 5.0mm 90mm Offset MC2-5070S / PA0684-015 / MAGEC 2 Rod, 5.0mm 70mm Standard MC2-5070R / PA0684-016 / MAGEC 2 Rod, 5.0mm 70mm Offset

During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a potential of failure of the sterile packaging barrier which could result in a hazardous situation where the device is no longer sterile.

On 11/01/2022, the firm sent an URGENT VOLUNTARY MEDICAL DEVICE RECALL Letter via Docusign/FedEx/email to customers (US/OUS Surgeons and Distributors) informing them that the packaging closure integrity (manufactured with an undersized O-ring of the MAGEC 2 (marketed as MAGEC X) packaged units. As a result of the undersized O-ring gland diameter, the O-ring compression is affected when the hard cap if affixed to the packaging tube. The lack of compression can create a situation where the integrity of the container closure system is compromised potentially impacting the sterile barrier system. Customer are instructed to: 1. Immediately quarantine any affected product. 2. Return all affected products. The NuVasive sales representative will be contacting customers to assist with the return actions. 3. Review this notification to ensure that affected personnel are aware of its contents. 4. For any devices that have been implanted, there are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedules. For questions or assistance - contact Sr. Director, Global Quality at 858-344-2667, email [email protected], or the NuVasive Sales Representative.