Trilliant Surgical recalls Tiger Cannulated Screw Systems with outdated cleaning protocols that could lead to infection if used improperly. Affected models were sold in 2018.
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 two types of surgical screw systems because their instructions for use and cleaning protocols were updated in 2018. Using outdated protocols could lead to infection risks during surgery.
The recall involves outdated instructions for cleaning and sterilizing surgical tools. If these protocols are followed incorrectly, there's a risk of infection during surgery. The updated protocols were released in 2018 to address this issue.
Surgical teams using the Tiger Cannulated Screw Systems (Models 210-00-001 and 210-00-101) that were sold starting in 2018. Surgeons and medical staff are most at risk if they use outdated cleaning procedures.
Check for the model numbers 210-00-001 (Tiger Cannulated Screw System) or 210-00-101 (Combination Tiger/Tiger Headless Cannulated Screw System) on the product label. The recall started in 2018 for these specific models.
Look for model numbers 210-00-001 or 210-00-101 on the product label to confirm if it's affected.
The recall occurs because the instructions for use and cleaning protocols were updated in 2018 to reduce infection risks during surgery.
The affected models are the Tiger Cannulated Screw System (Model 210-00-001) and Combination Tiger/Tiger Headless Cannulated Screw System (Model 210-00-101).
The recall does not require immediate action, but you should check the product label to confirm if it's affected. Updated protocols were released in 2018.
We’ve drafted a message you can send Trilliant Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1605-2020 — Trilliant Surgical Trilliant Surgical Hello, I own a Trilliant Surgical that is covered by recall Z-1605-2020 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.
