Gordian Surgical: Medical Device Recall in 2020 - (Recall #: Z-0398-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 22, 2020

Date Posted: November 11, 2020

Recall Number: Z-0398-2021

Event ID: 86483

Reason for Recall:

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

Status: Terminated

Product Quantity: 300 total devices

Code Information:

Catalog Number: GSTC1200 Lot Numbers: AS200009/3, Exp 14 FEB 2022 AS200012/4, Exp 23 MAR 2022

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated