Recall Z-0826-2020 ยท PGW Ear, Nose, And Throat Stereotaxic Instrument
Acclarent, Inc.
TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
| Date | Mar 6, 2019 |
| Status | Terminated |
| Reason | The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system. |
| Root cause | Device Design |
| Action | On 3/6/19, affected customers were contacted via Phone concerning the recall. On 3/12/19, the firm mailed a "Urgent Medical Device Recall" letter to affected customer via FedEx overnight. In addition to informing the customers about the recall, the letter asked customers to take the following actions: 1. Evaluate your current inventory of Acclarent TruDi Nav Suction Instruments with the identified lot numbers listed above. If you have inventory of the specific lots, DO NOT USE. Remove and return products immediately. 2. To return the products, complete BOTH customer acknowledgment and produc |
| Distribution | US: WI, IL, NE, CA, OH, NY OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180948 | TruDi NAV Suction Instruments Acclarent, Inc., Jul 20, 2018 |