Trilliant Surgical, LLC: Medical Device Recall in 2020 - (Recall #: Z-1611-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd 3S Hemi Toe Implant System, Model 111-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.

Product Classification:

Class II

Date Initiated: July 19, 2018

Date Posted: April 8, 2020

Recall Number: Z-1611-2020

Event ID: 84977

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.

Status: Terminated

Product Quantity: 9 systems

Code Information:

IFUs previous to Document #900-01-009 Rev. I and Cleaning and Sterilization Protocols previous to Document #900-06-008 Rev. H.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated