Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1142-2021 — 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

U.S. FDA — Device Enforcement · United States · 2021-01-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1142-2021
Date of alert
2021-01-13
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Covidien Llc
Product category
device
Product type
Devices
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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