BEUDAMED
    FDA Enforcement Class II Terminated

    Streamline MIS Navigation System Taps, Catalog numbers 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

    Recall: Z-0320-2021 · Reported November 11, 2020

    Enforcement

    Recall Number
    Z-0320-2021
    Event ID
    86591
    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 11, 2020
    Initiation Date
    September 11, 2020
    Classification Date
    October 31, 2020
    Termination Date
    May 23, 2024
    Address
    375 River Park Cir, N/A, Marquette, MI, 49855-1781, United States

    Description

    Streamline MIS Navigation System Taps, Catalog numbers 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

    Reason

    The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve.

    Code Info

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

    Distribution

    Product distributed to Surgalign, a distributor located in Michigan.

    Quantity

    143 units