medical Class II Updated 2020-04-08

Trilliant Surgical, LLC recalls Instructions for Use and Surgical Cleaning and Sterilization

Recalled Product

Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Large Cannulated Screw System, Model 215-00-001; and (2) Trilliant Surgical Ltd Large Cannulated Headless Screw System, Model 215-00-001. The firm name on the label is Trilliant Surgical Ltd., Houston, TX.

Hazard / Issue

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

Issued by

FDA

Affected States: AZ, CA, CT, FL, GA, IA, IL, IN, LA, MD, MI, MN, MO, MT, ND, NE, NH, NJ, OH, OK, PA, SD, TN, TX, VA, WA, WI, WY

Lot/Code Info: (1) Trilliant Surgical Tiger Large Cannulated Screw System - IFUs previous to Document #900-01-010 Rev. I and Cleaning and Sterilization Protocols previous to Document #900-06-009 Rev. F; and (2) Trilliant Surgical Large Cannulated Headless Screw System - IFUs previous to Document 900-01-014 Rev G and Cleaning and Sterilization Protocols previous to Document #900-06-012 Rev. D.

View official government recall

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