Recall Z-0135-2026— Iantrek Inc.
Class II · Ongoing
Class II FDA medical device recall by Iantrek Inc., initiated 2025-09-06. FDA's recall record names no specific 510(k) clearance for this event. 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 inner wall trabeculotomy.. Reason: Potential for compromised integrity of the sterile packaging..
- Recalling firm
- Iantrek Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-09-06
- Firm location
- Providence, RI, United States
Product description
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 inner wall trabeculotomy.
Reason for recall
Potential for compromised integrity of the sterile packaging.
Data sourced from openFDA. This site is unofficial and independent of the FDA.