X-Guide Handpiece Adaptor Sleeve 3, Model P010727

FDA device recall Z-1393-2024 · posted 2024-03-29 · Open, Classified

Recall details

Recalling firm

X-NAV Technologies, LLC

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.

Action taken

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.

Root cause

Use error

Status

Open, Classified

Product code

QRY

Quantity affected

154 units

Distribution

Worldwide distribution - US Nationwide and the countries of China, Europe, Japan.

Date initiated

2024-03-04

Date posted

2024-03-29

Location

Lansdale, PA

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