Trilliant Surgical recalls Tiger Headless Cannulated Screw System models due to outdated instructions for use and sterilization protocols. Updated documents are required to prevent potential safety issues.
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 specific surgical screw systems because their instructions for use and sterilization protocols were updated in 2018. This recall means healthcare providers must use the latest versions of these documents to ensure safe surgical procedures.
The recall involves outdated instructions for use and sterilization protocols. Using older versions without the updated documents could lead to improper surgical procedures or sterilization errors, though serious injury is not explicitly stated.
Healthcare providers using the Tiger Headless Cannulated Screw System models 212-00-001 and 210-00-101 are affected. Surgeons and medical staff who follow outdated instructions may face minor risks.
Check for the model numbers 212-00-001 or 210-00-101 on the product label. The manufacturer name on the label is Trilliant Surgical Ltd, Houston, TX. The recall occurred in 2018 for older versions of the instructions.
Verify that you have the latest version of the Instructions for Use (Document #900-01-004 Rev. P) and Cleaning and Sterilization Protocols (Document #900-06-007 Rev. F).
The recall is due to outdated Instructions for Use and Surgical Cleaning and Sterilization Protocols that were updated in 2018. Using older versions may lead to improper procedures.
The Tiger Headless Cannulated Screw System Model 212-00-001 and Combination Tiger Cannulated/Tiger Headless Cannulated Screw System Model 210-00-101 are affected.
No return is required; healthcare providers must use the updated instructions and protocols to ensure safe procedures.
We’ve drafted a message you can send Trilliant Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1606-2020 — Trilliant Surgical Trilliant Surgical Hello, I own a Trilliant Surgical that is covered by recall Z-1606-2020 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.
