Z-2253-2020 Class II Ongoing

Recalled by Covidien Llc — Mansfield, MA

Recall Details

Product Type
Devices
Report Date
June 10, 2020
Initiation Date
May 12, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12,610 total

Product Description

Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).

Reason for Recall

The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed.

Distribution Pattern

Worldwide distribution.

Code Information

Lots P9J1172Y P9K0452Y P9K0453Y P9K0454Y P9K1596Y P0B0996Y