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
Z-1142-2021
Product summary
- Firm
- Covidien Llc
- Event
- Event 87179
- Status
- Terminated
- Classification
- Class II
- Quantity
- 129 units WW
- Official record key
device-enforcement:Z-1142-2021
Official wording
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
Code information: Lot Number: SUH0709M
Distribution pattern: Worldwide distribution - US Nationwide distribution in the state of MA and the countries of France, French Guiana, Germany, Luxembourg, Spain, United Kingdom.
Derived failure modes
-
Unknown
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