Z-1142-2021Class II

Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left -

Name: Z-1142-2021 Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left -
Creator: Covidien Llc
Published: 2021-01-13
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-01-13 / Terminated / root cause: labeling and UDI

FDA source

Covidien Llc began a recall of Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of inguinal hernias via laparoscopic or... on 2021-01-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1142-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-13
Posted: 2021-02-22
Terminated: 2023-02-14
Recalling firm: Medtronic, Inc.
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
Product code: FTL Mesh, Surgical, Polymeric
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
Root cause tag: labeling and UDI
FDA 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 contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
Quantity in commerce: 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.
Product codes and lots: Lot Number: SUH0709M

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1142-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1142-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-03	2021-02-22

Product code FTL

K173796Class IIParietex 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

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)