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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86483

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
September 22, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Gordian Surgical

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0398-2021
Recall number
Z-0398-2021
Initiated
September 22, 2020
Classification
Class II
Status
Terminated
Recalling firm
Gordian Surgical
Quantity
300 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Inspect official wording and provenance

Reason for recall

Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device).

Code information

Catalog Number: GSTC1200 Lot Numbers: AS200009/3, Exp 14 FEB 2022 AS200012/4, Exp 23 MAR 2022

Distribution pattern

US Nationwide distribution including in the states of Texas and Michigan.