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U.S. Department of Health and Human Services

Class 2 Device Recall XGuide

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  Class 2 Device Recall XGuide see related information
Date Initiated by Firm March 04, 2024
Date Posted March 29, 2024
Recall Status1 Open3, Classified
Recall Number Z-1393-2024
Recall Event ID 94175
510(K)Number K232148  
Product Classification Dental navigation system - Product Code QRY
Product X-Guide Handpiece Adaptor Sleeve 3, Model P010727
Code Information UDI-DI: 00817421021503; Lot: 2306020012, 2310010012
Recalling Firm/
Manufacturer
X-NAV Technologies, LLC
1555 Bustard Rd Ste 75
Lansdale PA 19446-5731
Manufacturer Reason
for Recall
The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.
FDA Determined
Cause 2
Use error
Action An URGENT MEDICAL DEVICE RECALL dated 3/4/24 was sent to customers. Action To Be Taken by the User Identify if you possess any of the affected devices. The lot numbers of the affected devices are the following: 2308010012 2306020012 2310010012 If the lot number on your device is not one of the above, then that Adaptor Sleeve is not part of this Recall. If you have a defective device, quarantine the device so that it is prevented from being used. Finally, destroy the device or return to X-Nav Technologies, LLC. Return the response form. X-Nav will ship all affected users a new Handpiece Adaptor Sleeve to replace their defective unit free of charge. This notice needs to be passed on all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. (As appropriate) Please transfer this notice to other organizations on which this action has an impact. (As appropriate) Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. Please report all device-related incidents to the manufacturer, distributor or local representative, and the national Competent Authority if appropriate, as this provides important feedback.
Quantity in Commerce 154 units
Distribution Worldwide distribution - US Nationwide and the countries of China, Europe, Japan.
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = QRY and Original Applicant = X-Nav Technologies, LLC
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