—#185490

Product

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

FDA product code: FTL — Mesh, Surgical, Polymeric
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K173796
Affected lot / code info: Lot Number: SUH0709M

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Covidien Llc
Address: 15 Hampshire St, Mansfield, Massachusetts 02048-1113

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution in the state of MA and the countries of France, French Guiana, Germany, Luxembourg, Spain, United Kingdom.

Timeline

Recall initiated: 2021-01-13
Terminated: 2023-02-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185490. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.