Trilliant Surgical, LLC recalls Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist Sublatar Implant Syst

Recalled April 8, 2020 · FDA recall Z-1607-2020 · Trilliant Surgical

Hazard

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

Units

4 systems total for both Twist Sublatar and Disco Sublatar

Sold at

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.

Description

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

Product

Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist Sublatar Implant System, Model 112-00-001. The firm name on the label is Trilliant Surgical, Ltd, Houston, TX.

Manufacturer(s)

Trilliant Surgical, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →