BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-1608-2020 · Reported April 8, 2020

    Enforcement

    Recall Number
    Z-1608-2020
    Event ID
    84977
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Trilliant Surgical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 8, 2020
    Initiation Date
    July 19, 2018
    Classification Date
    March 30, 2020
    Address
    727 N Shepherd Dr Ste 100, N/A, Houston, TX, 77007-1320, United States

    Description

    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.

    Reason

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

    Code Info

    IFUs previous to Document #900-01-005 Rev. N and Cleaning and Sterilization Protocols previous to Document #900-06-015 Rev. C.

    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.

    Quantity

    4 systems total for both Disco Sublatar and Twist Sublatar