Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Instructions for Use and Surgical Cleaning and Sterilization Protocol for: Recalled by Trilliant Surgical, LLC Due to Instructions for Use (IFU) and Surgical Cleaning and...

Date: July 19, 2018
Company: Trilliant Surgical, LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Trilliant Surgical, LLC directly.

Affected Products

Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Headless Cannulated Screw System, Model 212-00-001; and (2) Combination Tiger Cannulated/Tiger Headless Cannulated Screw System, Model 210-00-101. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.

Quantity: 28 systems

Why Was This Recalled?

Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.

Where Was This Sold?

This product was distributed to 28 states: AZ, CA, CT, FL, GA, IL, IN, IA, LA, MD, MI, MN, MO, MT, NE, NH, NJ, ND, OH, OK, PA, SD, TN, TX, VA, WA, WI, WY

Affected (28 states)Not affected

About Trilliant Surgical, LLC

Trilliant Surgical, LLC has 13 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report