Recall Z-1142-2021 ยท FTL Mesh, Surgical, Polymeric
Covidien Llc
Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of inguinal hernias via laparoscopic or posterior open procedures Item Code: TECT1510AL
| Date | Jan 13, 2021 |
| Status | Terminated |
| Reason | 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 |
| Root cause | Under Investigation by 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 |
| Quantity | 129 units WW |
| Distribution | Worldwide distribution - US Nationwide distribution in the state of MA and the countries of France, French Guiana, Germany, Luxembourg, Spain, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173796 | Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PC Sofradim Production, Mar 9, 2018 |