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.
FDA Recall Z-0398-2021 · Posted None
Advertisement
Recalling FirmGordian Surgical
Recall StatusTerminated
Product CodeGAM
Date Initiated2020-09-22
Date Terminated2021-02-11
Product Quantity300 total devices
Reason for Recall
Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device).
Firm 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.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution including in the states of Texas and Michigan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement