Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Disco Subtalar Implant System, Model 112-00-001. 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-1608-2020
Quantity: 4 systems total for both Disco Sublatar and Twist Sublatar
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.