FDA recall Z-1142-2021

Covidien Llc · Class II · device

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 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

Distribution

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

Key facts

Status: Terminated
Initiation date: 2021-01-13
Report date: 2021-03-03
Termination date: 2023-02-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mansfield, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1142-2021