TroClose 1200 — Class II medical device recall Z-0398-2021
Terminated recall by Gordian Surgical, reported 2020-11-11, distributed nationwide. Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device).
| Recall number | Z-0398-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gordian Surgical, Misgav, N/A, Israel |
| Recall initiated | 2020-09-22 |
| Classified | 2020-11-03 |
| Reported by FDA | 2020-11-11 |
| Terminated | 2021-02-11 |
| Distributed | Nationwide (US) |
| Quantity | 300 devices |
| Reason classes | sterility |
| Lot numbers | AS200009/3, AS200012/4 |
| Model numbers | GSTC1200 |
| Expiration dates | 2022-02-14, 2022-03-23 |
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.
Reason for recall
Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0398-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.