FDA Device recall Z-0127-2024
TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
- FDA Device
- Class II
- ongoing
- Published 2023-11-01
On 2023-11-01 the FDA classified a Class II recall of TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005 by Acclarent, citing when using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended for use during s….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0127-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-21 |
| Published | 2023-11-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Acclarent |
| Distribution | AL, AZ, CA, CO, CT, DC, FL, HI, IA, ID, IL, KS, LA, MA, ME, MI, MN, MO, NC, NE, NY, OH, OK, OR, PA, SC, SD, TN, TX, WI |
Product
TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
Reason
When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended for use during surgical procedures of the Ear Nose and Throat (ENT) and ENT skull base surgery, which may cause delayed/prolonged surgery, cerebrospinal fluid leak, visual impairment, or skull base structural damage.
Identifiers
| code_info | TruDi Navigation System, UDI-DI: 10846835018639, software version: V2.3.1 Update (2.3.1.144 and 2.3.1.166) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0127-2024%22
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