FDA recall Z-1891-2024

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

Reason for recall

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

Distribution

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

Key facts

Status

Ongoing

Initiation date

2024-04-15

Report date

2024-06-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Haven, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1891-2024