Recall Z-0121-2024 ยท MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Medtronic Neuromodulation
SenSight Connector Plug, Model Number B31061.
| Date | Oct 18, 2023 (initiated Jan 20, 2023) |
| Status | Open, Classified |
| Reason | Medtronic is requesting return of a small number of units of the SenSight Connector Plug, Model B31061, due to a discrepancy in the Use By Date (UBD) printed on the label. |
| Root cause | Labeling Change Control |
| Action | Medtronic issued a MEDICAL DEVICE REMOVAL notice to its consignees on 01/20/2023 by mail. Consignees were asked to return any affected product they may have, and to forward this notification to those who need to be aware within the organization or to any location which the devices have been transferred. |
| Quantity | 65 devices |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.