Class II

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

Globus Medical, Inc. · April 3, 2025

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.

States Affected

NATIONWIDE

Quantity Affected

1 unit

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1657-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.