Lansdale, PA, United States
X-NAV Technologies, LLC recalls
2 recalls recorded since 2018, most recently on 4 March 2024. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 4 March 2024
- Reason
- The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.
- Distribution
- Worldwide distribution - US Nationwide and the countries of China, Europe, Japan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1393-2024, Z-1392-2024
- X-Guide Handpiece Adaptor Sleeve 3, Model P010727
- X-Guide Handpiece Adaptor Sleeve 1, Model P010701
Ongoing Class II Medical devices
- Recall started
- 28 September 2022
- 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-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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0222-2023
- X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.