BEUDAMED
    FDA Recall Terminated

    Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Large Cannulated Screw System, Model 215-00-001; and (2) Trilliant Surgical Ltd Large Cannulated Headless Screw System, Model 215-00-001. The firm name on the label is Trilliant Surgical Ltd., Houston, TX.

    Recall: Z-1612-2020 · Initiated July 19, 2018

    Recall

    Recall Number
    Z-1612-2020
    Event Number
    84977
    Firm
    Trilliant Surgical, LLC
    FEI Number
    3007420745
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    July 19, 2018
    Address
    727 N Shepherd Dr, Ste 100, Houston, TX, 77007-1320

    Description

    Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Large Cannulated Screw System, Model 215-00-001; and (2) Trilliant Surgical Ltd Large Cannulated Headless Screw System, Model 215-00-001. 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.

    Action

    The recalling firm issued letters as of 7/19/2018 via FedEx.

    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