Date Initiated by Firm |
January 20, 2023 |
Date Posted |
October 18, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0121-2024 |
Recall Event ID |
93083 |
PMA Number |
P960009S391 |
Product Classification |
Stimulator, electrical, implanted, for parkinsonian tremor - Product Code MHY
|
Product |
SenSight Connector Plug, Model Number B31061. |
Code Information |
GTIN 00763000426576, Lot Number 082U30721 |
Recalling Firm/ Manufacturer |
Medtronic Neuromodulation 7000 Central Ave Ne Minneapolis MN 55432-3568
|
For Additional Information Contact |
Medtronic Customer Service 800-962-9888
|
Manufacturer Reason for Recall |
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.
|
FDA Determined Cause 2 |
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 in Commerce |
65 devices |
Distribution |
US Nationwide Distribution |
Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
PMA Database |
PMAs with Product Code = MHY and Original Applicant = MEDTRONIC Inc.
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