BEUDAMED
    FDA Enforcement Class II Terminated

    Streamline MIS Navigation System Taps, Catalog Nos. 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN 04-S-FINDER-MDN 05-SCREWINS-CL-MDN 05-SIMPDRIVER-MDN Product Usage: intended to be used during the preparation and placement of screws from the Streamline TL and MIS Systems and preparation of screws from the Streamline OCT System during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.

    Recall: Z-0299-2021 · Reported November 4, 2020

    Enforcement

    Recall Number
    Z-0299-2021
    Event ID
    86559
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 4, 2020
    Initiation Date
    September 24, 2020
    Classification Date
    October 27, 2020
    Termination Date
    September 16, 2024
    Address
    375 River Park Cir, N/A, Marquette, MI, 49855-1781, United States

    Description

    Streamline MIS Navigation System Taps, Catalog Nos. 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN 04-S-FINDER-MDN 05-SCREWINS-CL-MDN 05-SIMPDRIVER-MDN Product Usage: intended to be used during the preparation and placement of screws from the Streamline TL and MIS Systems and preparation of screws from the Streamline OCT System during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.

    Reason

    The Streamline Navigation System taps have experienced binding with other devices.

    Code Info

    Lots 377520 371734 374791 374792 373438 371735 371736 377625 377806 371737 372819 371266 371733

    Distribution

    US Nationwide distribution including in the state of Michigan.

    Quantity

    420 units