BEUDAMED
    FDA Recall 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 · Initiated February 23, 2016

    Recall

    Recall Number
    Z-1391-2016
    Event Number
    73544
    Firm
    X-NAV Technologies, LLC
    FEI Number
    3011764595
    Product Code
    PLV
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 23, 2016
    Terminated
    November 1, 2016
    Address
    1555 Bustard Rd, Ste 75, Lansdale, PA, 19446-5731

    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

    Action

    The firm, X-Nav Technologies, LLC, sent a "Medical Device Recall" letter date 2/23/2016 via mail and email to customers indicating the issue and risks involved. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory of X-Clips and remove any product containing the affected lots; complete the enclosed Acknowledgement and Receipt form to record the lot numbers located on the labeling for parts and discard affected product and return form to firm by Email to: [email protected] or by Mail to: X-NAV TECHNOLOGIES, LLC, 1555 BUSTARD ROAD, SUITE 75,LANSDALE, PA. 19446, ATTN: Director, Quality Assurance and Regulatory Affairs, even if you have already used or no longer have possession of the X-Clips identified. Should you have any questions regarding this notification, please contact our Customer Service representatives at 267.436.0420 from 8:30a.m. to 5:30p.m. (EST) Monday-Friday.

    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)