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U.S. Department of Health and Human Services

Class 2 Device Recall XGuide Surgical Navigation System

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 Class 2 Device Recall XGuide Surgical Navigation Systemsee related information
Date Initiated by FirmFebruary 23, 2016
Create DateApril 14, 2016
Recall Status1 Terminated 3 on November 01, 2016
Recall NumberZ-1391-2016
Recall Event ID 73544
510(K)NumberK150222 
Product Classification Dental stereotaxic instrument - Product Code PLV
ProductX-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.
Code Information 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.
FEI Number 3011764595
Recalling Firm/
Manufacturer		 X-NAV Technologies, LLC
1555 Bustard Rd Ste 75
Lansdale PA 19446-5731
Manufacturer Reason
for Recall		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
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe 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.
Quantity in Commerce845 units (P007665)
DistributionUS Distribution to: FL, OR, NE, PA, NM, FL, VA, OH, WA, CA, MD, LA, ID, CN, TN, and DC.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = PLV
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