FDA recall Z-1237-2018

Product

Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has applications in open and minimally invasive general abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis.

Reason for recall

Product reportedly shutting down during use.

Distribution

Worldwide Distribution: US (Nationwide).

Key facts

Status

Terminated

Initiation date

2017-12-13

Report date

2018-04-04

Termination date

2020-04-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Haven, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1237-2018