X-NAV Technologies, LLC: Medical Device Recall in 2022 - (Recall #: Z-0222-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673

Product Classification:

Class II

Date Initiated: September 28, 2022

Date Posted: November 16, 2022

Recall Number: Z-0222-2023

Event ID: 91067

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.

Status: Ongoing

Product Quantity: 102 units

Code Information:

UDI-DI: (01)00817421020995 (10) 2007010010 Lot number: 2007010010

Distribution Pattern:

US Nationwide distribution and Foreign country of: Canada

Voluntary or Mandated:

Voluntary: Firm initiated