# FDA recall Z-1657-2025

> **Globus Medical, Inc.** · Class II · device recall initiated 2025-04-03.

## Product

MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;

## Reason for recall

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.

## Distribution

US Nationwide distribution in the state of AR.

## Key facts

- **Recall number:** Z-1657-2025
- **Recalling firm:** Globus Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-03
- **Report date:** 2025-04-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** West Norriton, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1657-2025

## Citation

> AI Analytics. FDA recall Z-1657-2025. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-1657-2025. Source: US FDA. Licensed CC0.

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