Recall record at a glance
| Official record | Z-0398-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Gordian Surgical |
| Report date | Nov 11, 2020 |
| Recall initiation date | Sep 22, 2020 |
| Quantity | 300 total devices |
| Location | Misgav, N/A, Israel |
Official product description
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.
Why the product was recalled
Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device).
Distribution information
US Nationwide distribution including in the states of Texas and Michigan.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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