Drug recall
TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for…
FDA recall event 94955 · Class II · Integra LifeSciences Corp.
Key facts
| Event ID | 94955 |
|---|---|
| Recall numbers | Z-2507-2024 |
| Recalling firm | Integra LifeSciences Corp. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jul 9, 2024 |
| Report date | Aug 14, 2024 |
| City | Princeton |
| State | NJ |
| Country | United States |
| FEI number | 3003418325 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: