X-Guide X-Mark Probe Tool Recall: Missing Weld Creates Aspiration Risk
X-NAV Technologies is recalling the X-Guide X-Mark Probe Tool because a critical weld may be missing, potentially allowing the probe tip to detach and fall into a patient's mouth during use, creating a risk of aspiration or swallowing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a risk-of-harm medical device where injury has not yet been reported. The hazard—foreign body aspiration during a dental procedure—is serious, but no actual illnesses or injuries are documented in the source text.
Plain-English summary
X-NAV Technologies, LLC is recalling the X-Guide X-Mark Probe Tool (Catalog Number P010673) used for registering edentulous patients. The product has a manufacturing defect in which one of the two welds connecting the probe tip to the shaft may be missing.
If the remaining weld breaks during X-Mark registration, the probe tip could detach and fall into a patient's mouth. Patients could then aspirate or swallow the detached tip.
The recall involves 102 units distributed nationwide in the United States and to Canada. The affected lot number is 2007010010.
The recalled product
- Product
- X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673
- Manufacturer
- X-NAV Technologies, LLC
- Affected units
- 102
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: (01)00817421020995 (10) 2007010010 Lot number: 2007010010
Distribution
Distributed nationwide across the United States.
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