X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673
Reported: November 16, 2022 Initiated: September 28, 2022 #Z-0222-2023
Product Description
X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673
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.
Details
- Recalling Firm
- X-NAV Technologies, LLC
- Units Affected
- 102 units
- Distribution
- US Nationwide distribution and Foreign country of: Canada
- Location
- Lansdale, PA
Frequently Asked Questions
What product was recalled? ▼
X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673. Recalled by X-NAV Technologies, LLC. Units affected: 102 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 16, 2022. Severity: Moderate. Recall number: Z-0222-2023.
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