X-Guide Handpiece Adaptor Sleeve 1, Model P010701 recallZ-1392-2024 · X-NAV Technologies, LLC · initiated Mar 4, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from X-NAV Technologies, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Use error
What the company is doing
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.
Recall details
- Recall number
- Z-1392-2024
- Status
- Open, Classified
- Initiated by the company
- Mar 4, 2024
- Posted by the FDA
- Mar 29, 2024
- Recalling firm
- X-NAV Technologies, LLC
- Quantity
- 88 units
- Product code
- QRY
- FDA submissions
- K232148
- Distribution
- Worldwide distribution - US Nationwide and the countries of China, Europe, Japan.
Product description
X-Guide Handpiece Adaptor Sleeve 1, Model P010701
Code information (models, lots, serial numbers)
UDI-DI: 00817421021480; Lot: 2308010012
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- X-GUIDE P010701Xnav Technologies LLC · Dental Stereotaxic Instrument1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 94175).
- Z-1393-2024 · Open, ClassifiedX-Guide Handpiece Adaptor Sleeve 3, Model P010727
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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