Recall Z-2507-2024 ยท PGW Ear, Nose, And Throat Stereotaxic Instrument
Integra LifeSciences Corp.
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
| Date | Aug 5, 2024 (initiated Jul 9, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | On July 9, 2024 URGENT VOLUNTARY MEDICAL DEVICE RECALL (REMOVAL) letters were sent to consignees. What Actions Are Required: 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 including a |
| Quantity | 265 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180948 | TruDi NAV Suction Instruments Acclarent, Inc., Jul 20, 2018 |