TroClose 1200 (Gordian Surgical) – endotoxin levels (2020)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Gordian Surgical Tchelet 17, Trendlines Building, Misgav Misgav Israel
Lot Codes / Batch Numbers
Catalog Number: GSTC1200 Lot Numbers: AS200009/3, Exp 14 FEB 2022 AS200012/4, Exp 23 MAR 2022
Products Sold
Catalog Number: GSTC1200 Lot Numbers: AS200009/3, Exp 14 FEB 2022 AS200012/4, Exp 23 MAR 2022
Gordian Surgical Tchelet 17, Trendlines Building, Misgav Misgav Israel is recalling TroClose 1200 - Product Usage: intended for use in a variety of gynecologic, general and urologic en due to Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device).. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device).
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026