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X-NAV Technologies, LLC recalls X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. C
Recalled November 16, 2022 · FDA recall Z-0222-2023 · X-NAV Technologies
Hazard
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. · FDA Class II
Units
102 units
Sold at
US Nationwide distribution and Foreign country of: Canada
Description
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.
Product
X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673
Manufacturer(s)
X-NAV Technologies, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →