Globus Medical, Inc. recalls MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;

Recall date

April 3, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1657-2025

FDA classification

Class II

Brand / firm

Globus Medical, Inc.

Sold / distributed

US Nationwide distribution in the state of AR.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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