Recall Z-0398-2021 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Gordian Surgical
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 com
| Date | Sep 22, 2020 |
| Status | Terminated |
| Reason | Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device). |
| Root cause | 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 | 300 total devices |
| Distribution | US Nationwide distribution including in the states of Texas and Michigan. |
| FDA record | Open on fda.gov |