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Recall Observatory FDA recall evidence

Device product

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

Z-0222-2023

September 28, 2022

Class II

Product summary

Firm
X-NAV Technologies, LLC
Event
Event 91067
Status
Ongoing
Classification
Class II
Quantity
102 units
Official record key
device-enforcement:Z-0222-2023

Official wording

Reason: 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.

Code information: UDI-DI: (01)00817421020995 (10) 2007010010 Lot number: 2007010010

Distribution pattern: US Nationwide distribution and Foreign country of: Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.