BEUDAMED
    FDA Enforcement Class II Ongoing

    UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool

    Recall: Z-1502-2022 · Reported August 10, 2022

    Enforcement

    Recall Number
    Z-1502-2022
    Event ID
    90548
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Neotract Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 10, 2022
    Initiation Date
    June 24, 2022
    Classification Date
    August 4, 2022
    Address
    4155 Hopyard Rd, N/A, Pleasanton, CA, 94588-8534, United States

    Description

    UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool

    Reason

    There is the potential that during implant deployment, the device may not properly deliver a implant.

    Code Info

    UDI/DI: 00814932020049 & 00814932020001; Lot #s: 73M2100393 73A2200670 73M2100394 73A2200671 73M2100395 73A2200672 73A2200012 73A2200673 73A2200013 73A2200674 73A2200014 73A2200832 73A2200221 73A2200841 73A2200222 73A2200859 73A2200223 73A2200905 73A2200224 73B2200116 73A2200225 73B2200466 73A2200226 73C2200567 73A2200473 New Lots added as of 08/01/2022: 73A2200834, 73C2200911, and 73C2201163

    Distribution

    US: AK AL AR AZ CA CO CT DC DE FL GA IA IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NY OH OK PA RI SC SD TN TX UT VA VT WI WV OUS: None

    Quantity

    18,722 systems