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Recall Observatory FDA recall evidence

Device product

Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis Model: SIGTRSB60AXT

Z-1891-2024

April 15, 2024

Class II

Product summary

Firm
Covidien, LP
Event
Event 94484
Status
Ongoing
Classification
Class II
Quantity
1681 units
Official record key
device-enforcement:Z-1891-2024

Official wording

Reason: Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery

Code information: GTIN: 10884521717633 20884521717630 Lot #: N3G1372Y

Distribution pattern: Worldwide - US Nationwide distribution in the state of NJ and the countries of Australia, Japan, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery