MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Reported: April 30, 2025 Initiated: April 3, 2025 #Z-1657-2025
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.
Details
- Recalling Firm
- Globus Medical, Inc.
- Units Affected
- 1 unit
- Distribution
- US Nationwide distribution in the state of AR.
- Location
- West Norriton, PA
Frequently Asked Questions
What product was recalled? ▼
MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;. Recalled by Globus Medical, Inc.. Units affected: 1 unit.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 30, 2025. Severity: Moderate. Recall number: Z-1657-2025.
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