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.
This recall has been terminated (originally issued July 19, 2018).
- Company
- Trilliant Surgical, Llc
- Recall Initiated
- July 19, 2018
- Recall Number
- Z-1612-2020
- Quantity
- 4 systems
- Firm Location
- Houston, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
Distribution
Distribution to US 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, and PR. There was government distribution and no military distribution. Foreign distribution to Australia, India, Italy, Panama, and Turkey.
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.
Root Cause
Labeling Change Control
Action Taken
The recalling firm issued letters as of 7/19/2018 via FedEx.