BEUDAMED
    FDA Enforcement Class II Ongoing

    Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-MDN 26-FTAP-40-MDN 26-FTAP-40-MDN 26-FTAP-45-MDN 26-S-FINDER-MDN Components of a surgical navigation device.

    Recall: Z-0322-2021 · Reported November 11, 2020

    Enforcement

    Recall Number
    Z-0322-2021
    Event ID
    86595
    Classification
    Class II
    Status
    Ongoing
    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 24, 2020
    Classification Date
    November 2, 2020
    Address
    375 River Park Cir, N/A, Marquette, MI, 49855-1781, United States

    Description

    Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-MDN 26-FTAP-40-MDN 26-FTAP-40-MDN 26-FTAP-45-MDN 26-S-FINDER-MDN Components of a surgical navigation device.

    Reason

    System does not include a drill guide.

    Code Info

    Lots 370855 373847 373848 373849 377629 373850 373846

    Distribution

    Distributed to one distributor in Michigan.

    Quantity

    76 units