Z-1392-2024Class II

X-Guide Handpiece Adaptor Sleeve 1, Model P010701

Name: Z-1392-2024 X-Guide Handpiece Adaptor Sleeve 1, Model P010701
Creator: X-NAV Technologies, LLC
Published: 2024-03-04
License: https://open.fda.gov/license/

X-NAV Technologies, LLC / initiated 2024-03-04 / Open, Classified / root cause: manufacturing process

FDA source

X-NAV Technologies, LLC began a recall of X-Guide Handpiece Adaptor Sleeve 1, Model P010701 on 2024-03-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1392-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-04
Posted: 2024-03-29
Recalling firm: X-NAV Technologies, LLC
Product: X-Guide Handpiece Adaptor Sleeve 1, Model P010701
Product code: QRY Dental Navigation System
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.
Root cause tag: manufacturing process
FDA root cause: 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: 88 units
Distribution: Worldwide distribution - US Nationwide and the countries of China, Europe, Japan.
Product codes and lots: UDI-DI: 00817421021480; Lot: 2308010012

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1392-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1392-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-03-29
Z-1393-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-03-29

Product code QRY

K232148Class IIX-Guide Surgical Navigation SystemX-Nav Technologies, LLC / cleared 2024-02-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)