BEUDAMED
    FDA Recall 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 · Initiated September 11, 2020

    Recall

    Recall Number
    Z-0320-2021
    Event Number
    86591
    Firm
    RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
    FEI Number
    1000115331
    Product Code
    OLO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 11, 2020
    Terminated
    May 23, 2024
    Address
    375 River Park Cir, Marquette, MI, 49855-1781

    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.

    Action

    On September 11, 2020, Pioneer Surgical sent out an advisory notice to their distributor (Surgalign) as a voluntary correction with no removal of devices from the field. However, after the advisory notice was distributed, a different issue related to the Streamline MIS Navigation taps becoming bound within Medtronic's Stealth Navigation System NavLock Tracker was reported. As a result, a second notification was sent out on September 24, 2020, changing the action to a voluntary recall. All instruments from the Streamline MIS Navigation System (as well as the Streamline TL Navigation System) were requested to be removed from the field. Please see RES 86559 for details on the September 24, 2020, recall. Customers are asked to do the following: -Remove all affected product from user sites and inventory locations -Return affected product to RTI Surgical, using RGA number - 63000897, along with a completed copy of the Acknowledgement and Receipt Form -Immediately notify any of your customers who have received the affected devices by providing them with a copy of the recall letter and response form for completion when returning affected devices.

    Distribution

    Product distributed to Surgalign, a distributor located in Michigan.

    Quantity

    143 units