BEUDAMED
    FDA Recall Terminated

    RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver

    Recall: Z-1393-2016 · Initiated March 18, 2016

    Recall

    Recall Number
    Z-1393-2016
    Event Number
    73659
    Firm
    RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
    FEI Number
    1000115331
    Product Code
    KWP
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    March 18, 2016
    Terminated
    September 12, 2016
    Address
    375 River Park Cir, Marquette, MI, 49855-1781

    Description

    RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver

    Reason

    Multiple lots of the 26-FNLDRIVER, may have reduced mechanical strength, resulting in driver tip fracturing during use.

    Action

    RTI Surgical Inc. initiated a voluntary recall of RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Final Driver, via written notices sent by e-mail and FedEx on 03/18/2016. Customers are requested to review all inventory, quarantine products listed in the recall, and to immediately return recalled products with the recall reply form, and the shipping labels and authorization numbers provided within 5 days of receiving notice. Replacement drivers are being sent to customers. Customers may contact Dan Nelson, Manager of Quality Systems, Phone: 906-226-4489, Fax: 906-226-4455, e-mail: [email protected].

    Distribution

    Domestic: AL, CO, CT, FL, IN, ID, IL, MI, MS, MO, NC, NY, TX Foreign: None VA/DOD: None