FDA recall Z-0636-2018

Product

Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

Reason for recall

Potential for failure of the device safety interlock. The safety interlock prevents an empty single-use loading unit from being fired a second time.

Distribution

Nationally

Key facts

Status

Terminated

Initiation date

2017-09-13

Report date

2018-02-28

Termination date

2019-06-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Haven, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0636-2018