Trilliant Surgical recalls Gridlock Ankle Plating instructions due to outdated IFU and sterilization protocols. Updated documents may cause surgical errors if not followed correctly.
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 Ankle Plating system's instructions for use and sterilization protocols because they were updated in 2018. This recall is important because outdated instructions could lead to surgical errors if healthcare providers follow the old versions instead of the revised ones.
The recall involves outdated Instructions for Use (IFU) and sterilization protocols that were updated in 2018. If healthcare providers continue using the old versions instead of the revised documents, it could lead to surgical errors during procedures.
Healthcare providers using the Gridlock Ankle Plating system with outdated instructions or sterilization protocols are affected. Surgeons and medical staff who follow the old instructions instead of the updated ones are at most risk.
Check for the Gridlock Ankle Plating System, Model 320-01-100. Look for IFUs dated before Document #900-01-011 Rev. K or Cleaning and Sterilization Protocols before Document #900-06-010 Rev. G.
Review the Instructions for Use to ensure they are updated to Document #900-01-011 Rev. K or later.
Ensure Sterilization Protocols are updated to Document #900-06-010 Rev. G or later.
The recall is for outdated Instructions for Use and Sterilization Protocols that were updated in 2018. Using older versions could lead to surgical errors.
The Gridlock Ankle Plating System, Model 320-01-100, with IFUs dated before Document #900-01-011 Rev. K or Sterilization Protocols before Document #900-06-010 Rev. G.
No return is required. Healthcare providers should update their instructions and protocols to the latest 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-1613-2020 — Trilliant Surgical Trilliant Surgical Hello, I own a Trilliant Surgical that is covered by recall Z-1613-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
