# FDA recall Z-0559-2023

> **NuVasive Specialized Orthopedics, Inc.** · Class II · device recall initiated 2022-11-01.

## Product

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  MC

## Reason for recall

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.

## Distribution

Distribution US nationwide including Puerto Rico; Chile, Israel, Jordan, New Zealand, Singapore, Sweden, Thailand, and United Arab Emirates.

## Key facts

- **Recall number:** Z-0559-2023
- **Recalling firm:** NuVasive Specialized Orthopedics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-01
- **Report date:** 2022-12-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Aliso Viejo, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0559-2023

## Citation

> AI Analytics. FDA recall Z-0559-2023. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/Z-0559-2023. Source: US FDA. Licensed CC0.

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