Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used Recalled by NuVasive Specialized Orthopedics, Inc. Due to During accelerated shelf-life extension studies it was noted...

Date: November 1, 2022
Company: NuVasive Specialized Orthopedics, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact NuVasive Specialized Orthopedics, Inc. directly.

Affected Products

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

Quantity: 1,873 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About NuVasive Specialized Orthopedics, Inc.

NuVasive Specialized Orthopedics, Inc. has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report