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Open, Classified

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.

FDA Recall Z-0135-2026 · Posted 2025-10-10

Recalling FirmIantrek Inc.
Recall StatusOpen, Classified
Product CodeHMZ
Date Initiated2025-09-06
Product Quantity198

Reason for Recall

Potential for compromised integrity of the sterile packaging.

Firm Action

Iantrek notified consignees on 09/06/2025 via email. Consignees were instructed to immediately remove and quarantine all affected units to prevent their use, notify personnel or customers if affected units were forwarded to other facilities. Consignees may also alternatively provide Iantrek with contact information so that they can notify them on the customer's behalf. An Iantrek representative will be contacting each consignee immediately to help facilitate removal, return and replacement of affected units. They will arrange to have replacement product shipped to consignees at no cost.

Root Cause

Process control

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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