Z-1657-2025 Class II Ongoing

Recalled by Globus Medical, Inc. — West Norriton, PA

Recall Details

Product Type
Devices
Report Date
April 30, 2025
Initiation Date
April 3, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit

Product Description

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 Pattern

US Nationwide distribution in the state of AR.

Code Information

Version/Model: MC2-5090S; UDI-DI (with lot nuber): (01)00887517834041(11)250311(17)300311(10)GB1607ET