Gordian Surgical recalls TroClose 1200 - Product Usage: intended for use in a variety of gynecologic, general and urologic endoscopic procedures…

Recall date

September 22, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0398-2021

FDA classification

Class II

Brand / firm

Gordian Surgical

Sold / distributed

US Nationwide distribution including in the states of Texas and Michigan.

Why it was recalled

Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

TroClose 1200 - Product Usage: intended for use in a variety of gynecologic, general and urologic endoscopic procedures, to create and maintain a port of entry and to facilitate the delivery of absorbable sutures and anchors through soft tissues of the body during endoscopic / laparoscopic surgery. The trocar may be used with or without visualization for primary and secondary insertions. It is comprised of a single patient use, bladeless Obturator designed to allow penetration and positioning at the required site within the abdomen, and several single use Cannulas, which serve as working channels for the procedure. The Cannulas are pre-loaded with two synthetic absorbable sutures, each attached to a synthetic absorbable anchor. The deployment of the anchors and sutures is achieved by utilizing a mechanism within the Obturator. The Cannula is 115 mm long and is compatible for use with laparoscopic devices of 5 - 12 mm outer diameter.