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Recall Observatory FDA recall evidence

Device product

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).

Z-2253-2020

May 12, 2020

Class II

Product summary

Firm
Covidien Llc
Event
Event 85689
Status
Ongoing
Classification
Class II
Quantity
12,610 total
Official record key
device-enforcement:Z-2253-2020

Official wording

Reason: 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.

Code information: Lots P9J1172Y P9K0452Y P9K0453Y P9K0454Y P9K1596Y P0B0996Y

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    manufacturing assembly error