Trilliant Surgical recalls Gridlock Plating System instructions for use due to outdated dry time parameters in 2018. Affected units have older IFU versions before Document #900-01-006 Rev. N.
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
Trilliant Surgical is recalling the Gridlock Plating System's instructions for use and sterilization protocols because they were updated with revised dry time parameters in 2018. This recall affects medical devices used in surgical settings where improper drying could lead to contamination or infection risks.
The outdated dry time parameters in the instructions could lead to improper sterilization if surgical cleaning protocols are followed incorrectly. This might increase the risk of contamination or infection during procedures.
Medical professionals using the Gridlock Plating System for surgical procedures. Those with older instructions for use (IFU) versions before Document #900-01-006 Rev. N are most at risk.
Check the label for the manufacturer name Trilliant Surgical Ltd in Houston, TX. Look for IFU versions older than Document #900-01-006 Rev. N or Cleaning and Sterilization Protocols older than Document #900-06-014 Rev. C.
Verify your instructions for use version is not older than Document #900-01-006 Rev. N.
Ensure your cleaning and sterilization protocols are not older than Document #900-06-014 Rev. C.
The recall is for updated dry time parameters in the instructions for use and surgical cleaning protocols to ensure proper sterilization.
Instructions for use versions older than Document #900-01-006 Rev. N and Cleaning and Sterilization Protocols older than Document #900-06-014 Rev. C.
No, the recall is for updated documentation, not the physical product. Users should check their current versions.
We’ve drafted a message you can send Trilliant Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1609-2020 — Trilliant Surgical Trilliant Surgical Hello, I own a Trilliant Surgical that is covered by recall Z-1609-2020 from Trilliant 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.
