X-NAV Technologies, LLC
X-NAV Technologies, LLC has 3 FDA enforcement events on this register (4 product records) between 2016 and 2024: 3 device; the busiest year was 2016 with 1.
0% of its events are Class I; the most common class is Class II (3). 2 events are listed as ongoing; the recalling firm's address is in PA.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 4 Mar 2024 | X-Guide Handpiece Adaptor Sleeve 1, Model P010701 | Device | Class II | 2 | Ongoing |
| 28 Sep 2022 | X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673 | Device | Class II | 1 | Ongoing |
| 23 Feb 2016 | X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures. | Device | Class II | 1 | Terminated |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has X-NAV Technologies, LLC had?
3 enforcement events (4 product records) on this register, 2016–2024: 3 device.
Are any X-NAV Technologies, LLC recalls ongoing?
2 events are listed as ongoing in the current openFDA export.
What class are X-NAV Technologies, LLC recalls?
3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.