Z-1142-2021 Class II Terminated
FDA device recall Z-1142-2021 was initiated by Covidien Llc on January 13, 2021 and is designated Class II. 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… The recall status is terminated (terminated February 14, 2023). Affected quantity: 129 units WW.
Recall Details
- Product Type
- Devices
- Report Date
- March 3, 2021
- Initiation Date
- January 13, 2021
- Termination Date
- February 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 129 units WW
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
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the state of MA and the countries of France, French Guiana, Germany, Luxembourg, Spain, United Kingdom.
Code Information
Lot Number: SUH0709M