Recalls / —
—#203403
Product
SenSight Connector Plug, Model Number B31061.
- FDA product code
- MHY — Stimulator, Electrical, Implanted, For Parkinsonian Tremor
- Device class
- Class 3
- Medical specialty
- Unknown
- PMA numbers
- P960009S391
- Affected lot / code info
- GTIN 00763000426576, Lot Number 082U30721
Why it was recalled
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 (FDA determination)
Labeling Change Control
Action the firm took
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.
Recalling firm
- Firm
- Medtronic Neuromodulation
- Address
- 7000 Central Ave Ne, Minneapolis, Minnesota 55432-3568
Distribution
- Distribution pattern
- US Nationwide Distribution
Timeline
- Recall initiated
- 2023-01-20
- Posted by FDA
- 2023-10-18
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #203403. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.