BEUDAMED
    FDA Recall 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 · Initiated October 10, 2019

    Recall

    Recall Number
    Z-1892-2020
    Event Number
    85374
    Firm
    Trilliant Surgical, LLC
    FEI Number
    3007420745
    Product Code
    HTW
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    October 10, 2019
    Terminated
    April 27, 2022
    Address
    727 N Shepherd Dr, Ste 100, Houston, TX, 77007-1320

    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.

    Action

    On 10/10/2019 the firm sent a "Urgent: Medical Device Recall" via: FedEx overnight to all consignees in receipt of the recalled product. In addition to informing consignees about the recall, they ask consignees to take the following actions: Check inventory stock for the identified device. 2. Locate and remove and/or discontinue use of identified device. 3. Return all products of the affected device to Trilliant Surgical in accordance with the included Return Response. 4. For questions regarding this communication, contact Trilliant Surgical at 800.495.2919. (Monday Friday, 8:00AM 5:00 CST)

    Distribution

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

    Quantity

    5 drill bits