The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0398-2021·Announced 2020-11-11

Gordian Surgical Recalls TroClose 1200 Devices Due to High Endotoxin Levels

Gordian Surgical is recalling 300 TroClose 1200 devices because endotoxin test results exceeded acceptable levels. The devices are used in endoscopic and laparoscopic surgeries.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a contamination hazard (endotoxin) that poses a risk of harm, but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity rating.

Plain-English summary

Gordian Surgical is recalling 300 units of the TroClose 1200 device. The recall was initiated because endotoxin test results were found to be above acceptable levels, specifically exceeding 20 EU/device in the LAL test. The TroClose 1200 is intended for use in gynecologic, general, and urologic endoscopic procedures to create and maintain a port of entry and facilitate the delivery of absorbable sutures and anchors.

The affected devices are identified by Catalog Number GSTC1200 and include Lot Numbers AS200009/3 (Expiration: 14 FEB 2022) and AS200012/4 (Expiration: 23 MAR 2022). These devices were distributed nationwide in the United States, including in the states of Texas and Michigan.

Healthcare providers and facilities should stop using the affected TroClose 1200 devices immediately and contact Gordian Surgical for instructions on how to return or dispose of the product. Patients who have had procedures using these devices should contact their healthcare provider if they have concerns or experience any adverse effects.

The recalled product

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…
Manufacturer
Gordian Surgical
Category
Medical Device — Surgical Instruments
Hazard
Affected units
300

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Related recalls

Same hazard · endotoxin contamination

See all →

Similar recalls