CLASS II ONGOING Device recall · Reported 14 Aug 2024 · FDA Enforcement Report
TruDi NAV Suction, 0 Degrees recalled by Integra LifeSciences
Integra LifeSciences is recalling TruDi NAV Suction, 0 Degrees, distributed in 35 states. The recall was initiated on 9 Jul 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2507-2024
- FDA event ID
- 94955
- Recalling firm
- Integra LifeSciences, Princeton, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Jul 2024
- FDA classified
- 5 Aug 2024
- Reported
- 14 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 9 Jul 2024 | Recall initiated by company | |
| 5 Aug 2024 | Classified by FDA | +27 days |
| 14 Aug 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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
Where it was distributed
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.
AlabamaArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippi
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI/DI: 10705031245877; Lot Codes: 2310160, 2309110, 2309150, 2308140, 2308160, 2308180.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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