Iantrek Inc.: Device Recall
Recall #Z-0135-2026 · 09/06/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0135-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Iantrek Inc.
- Status
- Ongoing
- Date Initiated
- 09/06/2025
- Location
- Providence, RI, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 198
Reason for Recall
Potential for compromised integrity of the sterile packaging.
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.
Distribution Pattern
US Nationwide distribution in the states of AL, AZ, CA, CT, DE, FL, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.
Other Recalls by Iantrek Inc.
- Class II: Risk 09/06/2025
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.