Trilliant Surgical, LLC: Medical Device Recall in 2020 - (Recall #: Z-1614-2020)
See the recall detail below. You can also see other recalls from the same firm in 2020.
Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Small Joint Reaming System, Model 311-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.
Class II
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
IFUs previous to Document #900-01-012 Rev. F and Cleaning and Sterilization Protocols previous to Document #900-06-011 Rev. E.
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: Firm initiated