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U.S. Department of Health and Human Services

Class 2 Device Recall TroClose 1200

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  Class 2 Device Recall TroClose 1200 see related information
Date Initiated by Firm September 22, 2020
Create Date November 03, 2020
Recall Status1 Terminated 3 on February 11, 2021
Recall Number Z-0398-2021
Recall Event ID 86483
510(K)Number K160564  K171494  
Product Classification Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
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.
Code Information Catalog Number: GSTC1200 Lot Numbers: AS200009/3, Exp 14 FEB 2022 AS200012/4, Exp 23 MAR 2022
Recalling Firm/
Manufacturer		 Gordian Surgical
Tchelet 17, Trendlines Building, Misgav
Misgav Israel
Manufacturer Reason
for Recall		 Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device).
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GAM and Original Applicant = GORDIAN SURGICAL LTD.
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