Recall archive / FDA device enforcement
TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use wit... — FDA record Z-2507-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 9, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation System during surgical procedures in ENT medicine and skull base surgery
- Reason
- Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when used with the TruDi Navigation System, may result in a discrepancy between the actual tip location and the visualized location displayed on the system.
- Classification
- Class II
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 265 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2507-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI/DI: 10705031245877; Lot Codes: 2310160, 2309110, 2309150, 2308140, 2308160, 2308180. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
The devices are only sold in the US. The following states have received the product: AL, AZ CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, PA, SC, SD, TN, TX, VA, VT, WI.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alabama
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Iowa
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- North Dakota
- Nebraska
- New Jersey
- New Mexico
- New York
- Ohio
- Pennsylvania
- South Carolina
- South Dakota
- Tennessee
- Texas
- Virginia
- Vermont
- Wisconsin
Dates in the source
- Report date
- Aug 14, 2024
- Recall initiation date
- Jul 9, 2024
- Center classification date
- Aug 5, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.