Gordian Surgical recalls TroClose 1200 surgical devices due to endotoxin levels exceeding safe limits in LAL tests. Affected units have specific lot numbers and expiration dates. Consumers should contact the manufacturer for details.
Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device).
Gordian Surgical is recalling TroClose 1200 surgical devices because endotoxin tests showed levels above the acceptable limit. This could pose a risk during surgery, though the recall does not specify if the hazard causes injury in normal use.
Endotoxins are harmful substances found in bacteria that can cause infections. The TroClose 1200 devices tested above the acceptable levels in endotoxin tests, which could lead to infections during surgery if the device is used.
Surgical patients and medical professionals who use the TroClose 1200 device during endoscopic procedures. Those with specific lot numbers and expiration dates are most at risk.
Check for the catalog number GSTC1200 and lot numbers AS200009/3 (expiring Feb 2022) or AS200012/4 (expiring Mar 2022) on the device packaging.
Reach out to Gordian Surgical for specific instructions on how to report the device and get replacement or refund.
The recall indicates endotoxin levels were above acceptable limits, but the official notice does not specify if the device causes injury in normal use.
Lot numbers AS200009/3 (expiring Feb 2022) and AS200012/4 (expiring Mar 2022) are affected.
Check the catalog number GSTC1200 and lot numbers on the device packaging.
We’ve drafted a message you can send Gordian Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0398-2021 — Gordian Surgical Gordian Surgical Hello, I own a Gordian Surgical that is covered by recall Z-0398-2021 from Gordian Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
