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U.S. Department of Health and Human Services

Class 2 Device Recall XNav

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 Class 2 Device Recall XNavsee related information
Date Initiated by FirmSeptember 28, 2022
Date PostedNovember 10, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0222-2023
Recall Event ID 91067
510(K)NumberK211701 
Product Classification Dental navigation system - Product Code QRY
ProductX-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673
Code Information UDI-DI: (01)00817421020995 (10) 2007010010 Lot number: 2007010010
Recalling Firm/
Manufacturer		 X-NAV Technologies, LLC
1555 Bustard Rd Ste 75
Lansdale PA 19446-5731
Manufacturer Reason
for Recall		Product missing one of two welds connecting the tip to the shaft, if the remaining weld breaks, it is possible that the tip could fall out during X-Mark registration and fall into the patient s mouth. In this case, the patient may aspirate or swallow the probe tip.
FDA Determined
Cause 2		Process control
ActionX-Nav issued letters dated 9/30/2022 via First Class Mail to potentially affected users on 10/3/22. Letter states reason for recall, health risk and action to take: The customers were instructed to cease use of the device until you have performed the inspection described on the second page of this letter. Review the pictures on the next page and compare them to the Probe Tool in your possession. After review, contact Customer Service at the contact options listed at the bottom of this page so that we may update our records with your findings. Report any of the below options. 1. PROBE TOOL IS GOOD. If your Probe Tool matches the good Probe Tool pictures above, it may be used as-is. 2. PROBE TOOL IS BROKEN. If your Probe Tool looks like either of the broken Probe Tool pictures above, we will send you a shipping label to return your existing Probe Tool. We will replace it with a new one free of charge. 3. YOU ARE UNSURE. If you are uncomfortable doing this inspection yourself or have doubt whether the Probe Tool is good, we will send you a shipping label to return your existing Probe Tool. We will replace it with a new one free of charge. x-navtech.com | Customer Service: 1-267-436-0420 Ext. 2 | orders@x-navtech.com
Quantity in Commerce102 units
DistributionUS Nationwide distribution and Foreign country of: Canada
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 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) Database510(K)s with Product Code = QRY
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