FDA recall Z-1833-2019

Product

SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT

Reason for recall

The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.

Distribution

Nationwide domestic distribution, worldwide foreign distribution.

Key facts

Status

Ongoing

Initiation date

2019-05-17

Report date

2019-06-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Haven, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1833-2019