Reported Nov 11, 2020 · Terminated
TroClose 1200 - Product Usage: intended for use in a variety of gynecologic, general and urologic endoscopic…
Gordian Surgical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Gordian Surgical · Tchelet 17, Trendlines Building, Misgav · Misgav, N/A · N/A
Is this the product you have?
- TroClose 1200 - Product Usageintended 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
- Lot codes and dates
- Catalog NumberGSTC1200
- Lot Numbers
AS200009/3Exp 14 FEB 2022 AS200012/4Exp 23 MAR 2022
- Amount recalled
- 300 total devices
Where it was sold
Why it was recalled
Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device).
This product could cause temporary or reversible health problems — stop using it.
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