BEUDAMED
    FDA Recall 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.

    Recall: Z-0135-2026 · Initiated September 6, 2025

    Recall

    Recall Number
    Z-0135-2026
    Event Number
    97640
    Firm
    Iantrek Inc.
    FEI Number
    3017891009
    Product Code
    HMZ
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    September 6, 2025
    Posted
    October 10, 2025
    Address
    216 Weybosset St, Ste 2, Providence, RI, 02903-3734

    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

    Potential for compromised integrity of the sterile packaging.

    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.

    Distribution

    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.

    Quantity

    198