Class II — Gordian Surgical
| Recalling firm | Gordian surgical Ltd |
|---|---|
| Registered facility | GORDIAN SURGICAL (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 chann… |
| Quantity | 300 total devices |
| Distribution | US Nationwide distribution including in the states of Texas and Michigan. |
| Initiated | 2020-09-22 |
| Classified | 2020-11-03 |
| Terminated | 2021-02-11 |
| Recall number | Z-0398-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Gordian Surgical (Z-0398-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86483/
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