X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. C
Summary
The FDA issued a Class II for X-Guide X-Mark Probe Tool -used for registering edentulous patients to the softw by X-NAV Technologies, LLC. 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-Ma.
Details
Source
Device Recall
External ID
Z-0222-2023
Action Date
2022-11-16
Status
Ongoing
Category
device
Product Description
X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673
Lot/Code Info: UDI-DI: (01)00817421020995 (10) 2007010010 Lot number: 2007010010
Quantity Affected: 102 units
Reason for Recall
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.
Distribution
US Nationwide distribution and Foreign country of: Canada
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-28
Company
Lansdale, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 134 device recalls issued in the same week, part of 403 device-related FDA actions this month.
X-NAV Technologies, LLC has 5 FDA actions in our database, including 3 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (X-NAV Technologies, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does X-NAV Technologies, LLC have FDA actions?
X-NAV Technologies, LLC has 5 FDA actions in our database, including 3 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0222-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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