Globus Medical, Inc.: Device Recall
Recall #Z-1657-2025 · 04/03/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1657-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Globus Medical, Inc.
- Status
- Ongoing
- Date Initiated
- 04/03/2025
- Location
- West Norriton, PA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
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.
Product Description
MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Distribution Pattern
US Nationwide distribution in the state of AR.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.