X-NAV Technologies, LLC: X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673

Hazard

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 from the source

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 Quantity: 102 units Lot/code info: UDI-DI: (01)00817421020995 (10) 2007010010 Lot number: 2007010010

UPC codes

00817421020995

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.