Drug recall
TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
FDA recall event 89170 · Class II · Acclarent, Inc.
Key facts
| Event ID | 89170 |
|---|---|
| Recall numbers | Z-0415-2022 |
| Recalling firm | Acclarent, Inc. |
| Product type | Devices |
| Products | TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verification of device location in the patient anatomy. If the surgeon does not detect… |
| Initiation date | Nov 12, 2021 |
| Report date | Dec 29, 2021 |
| City | Irvine |
| State | CA |
| Country | United States |
| FEI number | 3005172759 |
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: