Recall Z-1392-2024 ยท QRY Dental Navigation System
X-NAV Technologies, LLC
X-Guide Handpiece Adaptor Sleeve 1, Model P010701
| Date | Mar 29, 2024 (initiated Mar 4, 2024) |
| Status | Open, Classified |
| Reason | 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 | 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 Ada |
| Quantity | 88 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of China, Europe, Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232148 | X-Guide Surgical Navigation System X-Nav Technologies, LLC, Feb 21, 2024 |