BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated September 24, 2020

    Recall

    Recall Number
    Z-0322-2021
    Event Number
    86595
    Firm
    RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
    FEI Number
    1000115331
    Product Code
    OLO
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    September 24, 2020
    Posted
    November 2, 2020
    Address
    375 River Park Cir, Marquette, MI, 49855-1781

    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.

    Action

    On September 24, 2020, the firm sent an Urgent Medical Devices Recall letter to customers to inform them of the product issue. Customers were instructed to remove affected product from all user sites and inventory locations. Customers are to return these instrument systems to RTI Surgical using RGA number 63000897 along with a completed copy of the Acknowledgement and Receipt Form. If the product has been further distributed, please immediately notify your customers by providing them a copy of the recall letter and the response form for completion.

    Distribution

    Distributed to one distributor in Michigan.

    Quantity

    76 units