Reported Apr 30, 2025 · Ongoing
MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Globus Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Globus Medical, Inc. · 2560 General Armistead Ave · West Norriton, PA · 19403-5214
Is this the product you have?
MAGEC 2 Rod5.0mm 90mm Standard
- Version/ModelMC2-5090S
- Lot codes and dates
- Version/ModelMC2-5090S
- UDI-DI (with lot nuber)(01)00887517834041(11)250311(17)300311(10)GB1607ET
- Amount recalled
- 1 unit
Where it was sold
- Nationwide
- 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.
This product could cause temporary or reversible health problems — stop using it.
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