Z-0398-2021Class II

TroClose 1200 -

Name: Z-0398-2021 TroClose 1200 -
Creator: Gordian Surgical
Published: 2020-09-22
License: https://open.fda.gov/license/

Gordian Surgical / initiated 2020-09-22 / Terminated / root cause: manufacturing process

FDA source

Gordian Surgical began a recall of 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... on 2020-09-22. FDA classified it as Class II and gives the reason as "Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0398-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-22
Posted: 2020-11-03
Terminated: 2021-02-11
Recalling firm: Gordian Surgical
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.
Product code: GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Reason for recall: Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: All associated LOTs shall be accounted for and all devices in those lots. Since only two LOTs are affected and only two costumers/distributors are in possession of said LOTs no failed attempt to correspond with them is expected. If any of the distributors fails to respond, a Gordian costumer representative will personally go to location to follow through on the process indicated.
Quantity in commerce: 300 total devices
Distribution: US Nationwide distribution including in the states of Texas and Michigan.
Product codes and lots: Catalog Number: GSTC1200 Lot Numbers: AS200009/3, Exp 14 FEB 2022 AS200012/4, Exp 23 MAR 2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0398-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0398-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-11	2020-11-03

Product code GAM

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)