X-NAV Technologies, LLC X-Guide Handpiece Adaptor Sleeve 1, Model P010701 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
X-Guide Handpiece Adaptor Sleeve 1, Model P010701
Brand
X-NAV Technologies, LLC
Lot Codes / Batch Numbers
UDI-DI: 00817421021480, Lot: 2308010012
Products Sold
UDI-DI: 00817421021480; Lot: 2308010012
X-NAV Technologies, LLC is recalling X-Guide Handpiece Adaptor Sleeve 1, Model P010701 due to The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not f. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026