FDA recall Z-0222-2023

X-NAV Technologies, LLC · Class II · device

Product

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

US Nationwide distribution and Foreign country of: Canada

Key facts

Status
Ongoing
Initiation date
2022-09-28
Report date
2022-11-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lansdale, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0222-2023