Misgav, N/A, Israel
Gordian Surgical recalls
1 recall recorded since 2018, most recently on 22 September 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 22 September 2020
- Terminated
- 11 February 2021
- Reason
- Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device).
- Distribution
- US Nationwide distribution including in the states of Texas and Michigan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0398-2021
- 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 anc
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.