medical Class II Updated 2025-04-30

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

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Version/Model: MC2-5090S; UDI-DI (with lot nuber): (01)00887517834041(11)250311(17)300311(10)GB1607ET
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