Trilliant Surgical recalls outdated instructions for use and sterilization protocols for Tiger Large Cannulated Screw Systems that could lead to infection if improperly cleaned.
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Trilliant Surgical is recalling outdated instructions for use and sterilization protocols for two types of surgical screws. Using the old instructions might lead to improper cleaning and infection risks.
The recall involves outdated instructions for use and sterilization protocols that could lead to improper cleaning if followed. This might increase the risk of infection during surgical procedures.
Surgical professionals using Trilliant Surgical's Tiger Large Cannulated Screw Systems with outdated instructions or sterilization protocols. The risk is low as the issue relates to outdated documentation rather than physical defects.
Check for the model number 215-00-001 on the label. The recall applies to Tiger Large Cannulated Screw Systems and Large Cannulated Headless Screw Systems with instructions or protocols older than Document #900-01-010 Rev. I and Document #900-01-014 Rev. G respectively.
Replace outdated instructions with the latest version (Document #900-01-010 Rev. I for Tiger Large and Document #900-01-014 Rev. G for Large Cannulated Headless).
No, the recall is for outdated instructions and protocols, not the physical product. You can continue using the system with updated instructions.
The model number is 215-00-001 for both Tiger Large Cannulated Screw System and Large Cannulated Headless Screw System.
Check the label for the model number 215-00-001 and look for instructions older than Document #900-01-010 Rev. I or protocols older than Document #900-01-014 Rev. G.
We’ve drafted a message you can send Trilliant Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1612-2020 — Trilliant Surgical Trilliant Surgical Hello, I own a Trilliant Surgical that is covered by recall Z-1612-2020 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.
