FDA Device recall Z-0222-2023
X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration
- FDA Device
- Class II
- ongoing
- Published 2022-11-16
On 2022-11-16 the FDA classified a Class II recall of X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration by X Nav Technologies, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0222-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-28 |
| Published | 2022-11-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | X Nav Technologies |
| Distribution | US |
Product
X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673
Reason
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.
Identifiers
| code_info | UDI-DI: (01)00817421020995 (10) 2007010010 Lot number: 2007010010 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0222-2023%22
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