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Gordian Surgical recalls TroClose 1200 - Product Usage: intended for use in a variety of gynecologic, general and urologic endoscopic procedures,
Recalled November 11, 2020 · FDA recall Z-0398-2021 · Gordian Surgical
Hazard
Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device). · FDA Class II
Units
300 total devices
Sold at
US Nationwide distribution including in the states of Texas and Michigan.
Description
Endotoxin test results found above the acceptable levels in LAL test (above 20EU/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.
Manufacturer(s)
Gordian Surgical
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →