BEUDAMED
    FDA Enforcement Class II Terminated

    X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures.

    Recall: Z-1391-2016 · Reported April 20, 2016

    Enforcement

    Recall Number
    Z-1391-2016
    Event ID
    73544
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    X-NAV Technologies, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    April 20, 2016
    Initiation Date
    February 23, 2016
    Classification Date
    April 14, 2016
    Termination Date
    November 1, 2016
    Address
    1555 Bustard Rd Ste 75, N/A, Lansdale, PA, 19446-5731, United States

    Description

    X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures.

    Reason

    The X-Guide system utilizes an X-Clip (PN P007665) which contains fiducials to assist with registration of the patient anatomy. The X-Clip is a device worn intraorally by a patient during the CT scan and guided surgery procedures. The X-Clip contains three fiducial markers made from a Stainless Steel material. The X-Nav specification requires these fiducials be fabricated from Stainless Steel 3

    Code Info

    Model Numbers: P007665 X-Clip; Component of System P007839. Note: P007665 X-Clip Component is distributed as X-Clip Bulk Kit PN P008381, package of 12 pieces P007665.

    Distribution

    US Distribution to: FL, OR, NE, PA, NM, FL, VA, OH, WA, CA, MD, LA, ID, CN, TN, and DC.

    Quantity

    845 units (P007665)