Recall Z-0415-2022 · PGW Ear, Nose, And Throat Stereotaxic Instrument
Acclarent, Inc.
TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
| Date | Nov 12, 2021 |
| Status | Open, Classified |
| Reason | 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 the accuracy error, this could lead to an intraprocedural delay, a potential for reversible tissue damage or damage to the carotid artery, CSF leak, or damage to optic nerve. |
| Root cause | Process control |
| Action | On 11/12/21, recall notices were sent to OR Directors, Risk Managers, or Material Managers. Customers were asked to do the following: 1) Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). 2) Remove the product subject to this recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3) If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider in |
| Quantity | 1543 |
| Distribution | US: AZ, MI, IA, LA, IL, VA, SC, NY, IN, OR, SD, TX, PA, NE, FL, CT, MN, NV, CA, NJ, UT, AL, MA, WI, TN, WV, OH, NC, KY, HI¿, OK, GA, CO, MO, WY, MS, NH, HI, MD, ID |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180948 | TruDi NAV Suction Instruments Acclarent, Inc., Jul 20, 2018 |