Reported Nov 16, 2022 · Ongoing
X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration.…
X-NAV Technologies, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: X-NAV Technologies, LLC · 1555 Bustard Rd Ste 75 · Lansdale, PA · 19446-5731
Is this the product you have?
- X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration
- Catalog NumberP010673
- Lot codes and dates
- UDI-DI(01)00817421020995 (10) 2007010010
- Lot number2007010010
- Amount recalled
- 102 units
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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