FDA Device recall Z-1392-2024
X-Guide Handpiece Adaptor Sleeve 1, Model P010701
- FDA Device
- Class II
- ongoing
- Published 2024-04-10
On 2024-04-10 the FDA classified a Class II recall of X-Guide Handpiece Adaptor Sleeve 1, Model P010701 by X Nav Technologies, citing 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 h….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1392-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-04 |
| Published | 2024-04-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | X Nav Technologies |
| Distribution | US |
Product
X-Guide Handpiece Adaptor Sleeve 1, Model P010701
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.
Identifiers
| code_info | UDI-DI: 00817421021480; Lot: 2308010012 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1392-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.