[pending] C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description:
Pending LLM rewrite. Source: FDA_DEVICE Z-0135-2026.
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
Potential for compromised integrity of the sterile packaging.
The recalled product
- Product
- C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microinterventional Goniotomy Instrument is a sterile single use disposable manual surgical instrument used in ophthalmic procedures for ab interno goniotomy and inne
- Manufacturer
- Iantrek 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 (5)
- 1. Model Number: CRX-120
- UDI: +B962CRX1200/$$7351729/16D20250501/14D20260501/Q1$
- Lot Number 351729
- Lot Number: 351759
- Exp date 05/2026.
Distribution
Distributed nationwide across the United States.
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