Recall Z-1142-2021— Covidien Llc

Name: FDA recall Z-1142-2021
Creator: U.S. Food and Drug Administration
Published: 2021-01-13

Class II · Terminated

Class II FDA medical device recall by Covidien Llc, initiated 2021-01-13, terminated 2023-02-14. It names one FDA 510(k) clearance: K173796. 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. 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.

Recalling firm: Covidien Llc
Classification: Class II
Status: Terminated
Initiated: 2021-01-13
Terminated: 2023-02-14
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K173796 — Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)Sofradim Production·cleared 2018-03-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.