# FDA recall Z-0528-2022

> **NuVasive Specialized Orthopedics, Inc.** · Class II · device recall initiated 2019-06-25.

## Product

MAGEC 1 System

## Reason for recall

Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-0528-2022
- **Recalling firm:** NuVasive Specialized Orthopedics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-06-25
- **Report date:** 2022-02-02

- **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-0528-2022

## Citation

> AI Analytics. FDA recall Z-0528-2022. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0528-2022. Source: US FDA. Licensed CC0.

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