[pending] MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Pending LLM rewrite. Source: FDA_DEVICE Z-1657-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
- Manufacturer
- Globus Medical, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Version/Model: MC2-5090S
- UDI-DI (with lot nuber): (01)00887517834041(11)250311(17)300311(10)GB1607ET
Distribution
Distributed nationwide across the United States.
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