BEUDAMED
    FDA Enforcement Class II Terminated

    3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)00812926029696 - Product Usage: A drill bit facilitates implant insertion

    Recall: Z-1892-2020 · Reported May 13, 2020

    Enforcement

    Recall Number
    Z-1892-2020
    Event ID
    85374
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Trilliant Surgical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 13, 2020
    Initiation Date
    October 10, 2019
    Classification Date
    May 5, 2020
    Termination Date
    April 27, 2022
    Address
    727 N Shepherd Dr Ste 100, N/A, Houston, TX, 77007-1320, United States

    Description

    3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)00812926029696 - Product Usage: A drill bit facilitates implant insertion

    Reason

    Labeling Error; specifically, drill bits from lots # TSL008495A are marked with the lot # of TSL008495. This could lead to parts being misidentified and impact device traceability.

    Code Info

    Lot # TSL008495A

    Distribution

    US Nationwide distribution in the state of CA. OUS: None

    Quantity

    5 drill bits