BEUDAMED
    FDA Enforcement Class II Ongoing

    X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673

    Recall: Z-0222-2023 · Reported November 16, 2022

    Enforcement

    Recall Number
    Z-0222-2023
    Event ID
    91067
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    X-NAV Technologies, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 16, 2022
    Initiation Date
    September 28, 2022
    Classification Date
    November 10, 2022
    Address
    1555 Bustard Rd Ste 75, N/A, Lansdale, PA, 19446-5731, United States

    Description

    X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673

    Reason

    Product missing one of two welds connecting the tip to the shaft, if the remaining weld breaks, it is possible that the tip could fall out during X-Mark registration and fall into the patient s mouth. In this case, the patient may aspirate or swallow the probe tip.

    Code Info

    UDI-DI: (01)00817421020995 (10) 2007010010 Lot number: 2007010010

    Distribution

    US Nationwide distribution and Foreign country of: Canada

    Quantity

    102 units