X-NAV Technologies, LLC Recall 91067
Description: X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673
X-NAV Technologies, LLC Recall 91067 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0222-2023 |
| Event ID | 91067 |
| Event Description | X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673 |
| Product Type | Devices |
| Distribution | US Nationwide distribution and Foreign country of: Canada |
| Quantity | 102 units |
| Recall 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. |
| Device Classification | 20221116 |
| Device Code Info | UDI-DI: (01)00817421020995 (10) 2007010010 Lot number: 2007010010 |
| Center Classification Date | 20221110 |
| Recall Initiation Date | 20220928 |
| Recalling Firm | X-NAV Technologies, LLC |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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