X-NAV Technologies, LLC recalls X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. C…

Recall date

September 28, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0222-2023

FDA classification

Class II

Brand / firm

X-NAV Technologies, LLC

Sold / distributed

US Nationwide distribution and Foreign country of: Canada

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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