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
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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