FDA-Device2022-11-16Class II
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
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.
Sold states
US Nationwide distribution and Foreign country of: Canada
Affected count
102 units
Manufactured in
1555 Bustard Rd Ste 75, N/A, Lansdale, PA, United States
Products
X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0222-2023Don't want to check this manually?
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