FDA
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.
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
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.