Recall Z-0535-2022 ยท GZL Electrode, Depth
DIXI MEDICAL USA
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use
| Date | Dec 9, 2021 |
| Status | Terminated |
| Reason | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| Root cause | Under Investigation by firm |
| Action | Dixi Medical issued Urgent Medical Device Letter on 12/9/21. Letter states reason for recall, health risk and action to take: 1. Examine your inventory for the affected product. Any available stock must be quarantined immediately and placed in a secure location to prevent further usage. 2. Please use the response form to record and return the stock back to the manufacturer. 3. The returned stock will be replaced with compliant products. 4. Please complete and return the attached Customer Response Form to Ann Cirner, ann.cirner@diximedus.com (248)845-3494, even if you do not have affected produ |
| Quantity | 1894 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170959 | DIXI Medical Microdeep Depth Electrode Dixi Medical, Nov 24, 2017 |