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Globus Medical, Inc. recalls MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Recalled April 30, 2025 · FDA recall Z-1657-2025 · Globus Medical
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. · FDA Class II
Units
1 unit
Sold at
US Nationwide distribution in the state of AR.
Description
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.
Product
MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Manufacturer(s)
Globus Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →