Recall Z-0127-2024 ยท PGW Ear, Nose, And Throat Stereotaxic Instrument
Acclarent, Inc.
TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
| Date | Oct 20, 2023 (initiated Sep 21, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Software Design Change |
| Action | On 9/21/23, correction notices were mailed to customers who were asked to do the following: Please cease using the affected curette device with the affected navigation system until the new version of navigation system software version 2.3.2 is installed. 2. Please do not return any of the curettes within your inventory. 3. Complete and return the business response form via email to OneMD-Field-Actions@its.jnj.com 4. Forward this notice to any personnel in your facility that needs to be informed. 5. If any of the affected products have been forwarded to another facility, contact that facility |
| Quantity | 141 |
| Distribution | US: CA, IL, WI, MA, TX, CO, FL, ID, KS, OH, OR, NE, MO, AZ, HI, TN, NY, ME, SC, NC, CT, DC, MN, LA, OK, PA, AL, IA, MI, SD |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192397 | TruDi Navigation System Biosense Webster, Jan 30, 2020 |