Z-0222-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 16, 2022
- Initiation Date
- September 28, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 102 units
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.
Distribution Pattern
US Nationwide distribution and Foreign country of: Canada
Code Information
UDI-DI: (01)00817421020995 (10) 2007010010 Lot number: 2007010010