Recall StatusTerminated
Date Initiated2021-01-13
Date Terminated2023-02-14
Product Quantity129 units WW
Reason for Recall
incorrect device is contained in the package. The packaging label indicates that the device is for left side use, the product inside the package is for right side use. Use of an opposite side mesh can result in implant failure and hernia recurrence
Firm Action
Medtronic issued Urgent Medical Device Recall letter via Federal Express and/or certified mail beginning January 13, 2021. The letter states reason for recall, health risk and action to take::
" Immediately quarantine and discontinue use of the affected item codes and lots.
" Return affected product.
" Forward the information to anyone who they have distributed affected Covidien Parietex" Hydrophilic Anatomical Mesh.
" Complete the Recalled Product Return Form.
Inventory within Medtronic control and customer returned products will be scrapped.
Questions regarding this communication, please contact your Medtronic
representative or Customer Service at 800-962-9888, option 2.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the state of MA and the countries of France,
French Guiana, Germany, Luxembourg, Spain, United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.