Device product
Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027 - 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-2255-2020
Product summary
- Firm
- Covidien Llc
- Event
- Event 85689
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 12,610 total
- Official record key
device-enforcement:Z-2255-2020
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 P9J0368Y P9J0369Y P9J0517Y P9K1300Y
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Manufacturing or process control
manufacturing assembly error