X-Guide Handpiece Adaptor Sleeve 3, Model P010727
- Company
- X-Nav Technologies, Llc
- Recall Initiated
- March 4, 2024
- Posted
- March 29, 2024
- Recall Number
- Z-1393-2024
- Quantity
- 154 units
- Firm Location
- Lansdale, PA
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.
Distribution
Worldwide distribution - US Nationwide and the countries of China, Europe, Japan.
Lot / Code Info
UDI-DI: 00817421021503; Lot: 2306020012, 2310010012
Root Cause
Use error
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.