Events

Recall of Device Recall XGuide Surgical Navigation System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by X-NAV Technologies, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73544
  • Event Risk Class
    Class 2
  • Event Number
    Z-1391-2016
  • Event Initiated Date
    2016-02-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144440
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Dental stereotaxic instrument - Product Code PLV
  • 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: Vigilance@X-Navtech.com 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.

Device

Device Recall XGuide Surgical Navigation System
  • Model / Serial
    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.
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to: FL, OR, NE, PA, NM, FL, VA, OH, WA, CA, MD, LA, ID, CN, TN, and DC.
  • Product 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.
  • Manufacturer
    X-NAV Technologies, LLC

Manufacturer

X-NAV Technologies, LLC
  • Manufacturer Address
    X-NAV Technologies, LLC, 1555 Bustard Rd Ste 75, Lansdale PA 19446-5731
  • Manufacturer Parent Company (2017)
    X-Nav Technologies LLC
  • Source
    USFDA