FDA-Device2025-04-30Class II
MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Globus Medical, Inc.
Hazard
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.
Sold states
US Nationwide distribution in the state of AR.
Affected count
1 unit
Manufactured in
2560 General Armistead Ave, N/A, West Norriton, PA, United States
Products
MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1657-2025Don't want to check this manually?
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