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Recall Observatory FDA recall evidence

Device product

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.

Z-0398-2021

September 22, 2020

Class II

Product summary

Firm
Gordian Surgical
Event
Event 86483
Status
Terminated
Classification
Class II
Quantity
300 total devices
Official record key
device-enforcement:Z-0398-2021

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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