Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-0135-2026

September 06, 2025

Class II

Product summary

Firm
Iantrek Inc.
Event
Event 97640
Status
Ongoing
Classification
Class II
Quantity
198
Official record key
device-enforcement:Z-0135-2026

Official wording

Reason: Potential for compromised integrity of the sterile packaging.

Code information: 1. Model Number: CRX-120; UDI: +B962CRX1200/$$7351729/16D20250501/14D20260501/Q1$; Lot Number 351729; Exp date 05/2026. 2. Model Number: CRX-120 UDI: +B962CRX1200/$$7351759/16D20250501/14D20260501/Q1%; Lot Number: 351759; Exp date 05/2026.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for compromised integrity of the sterile packaging.