X-Guide X-Mark Probe Tool -used for registering recall
X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673
Why was X-Guide X-Mark Probe Tool -used for registering 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: (01)00817421020995 (10) 2007010010 Lot number: 2007010010
- Product
- X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673
- Recalling firm
- X-NAV Technologies, LLC
- Quantity
- 102 units
- Distribution
- US Nationwide distribution and Foreign country of: Canada
- Recall date
- November 16, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)