X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing...
FDA Device Recall #Z-0222-2023 — Class II — September 28, 2022
Recall Summary
| Recall Number | Z-0222-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 28, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | X-NAV Technologies, LLC |
| Location | Lansdale, PA |
| Product Type | Devices |
| Quantity | 102 units |
Product Description
X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673
Reason for Recall
Product missing one of two welds connecting the tip to the shaft, if the remaining weld breaks, it is possible that the tip could fall out during X-Mark registration and fall into the patient s mouth. In this case, the patient may aspirate or swallow the probe tip.
Distribution Pattern
US Nationwide distribution and Foreign country of: Canada
Lot / Code Information
UDI-DI: (01)00817421020995 (10) 2007010010 Lot number: 2007010010
Other Recalls from X-NAV Technologies, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1393-2024 | Class II | X-Guide Handpiece Adaptor Sleeve 3, Model P010727 | Mar 4, 2024 |
| Z-1392-2024 | Class II | X-Guide Handpiece Adaptor Sleeve 1, Model P010701 | Mar 4, 2024 |
| Z-1391-2016 | Class II | X-Guide Surgical Navigation System, X-Clip Bulk... | Feb 23, 2016 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.