BEUDAMED
    FDA Recall Terminated

    ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003

    Recall: Z-1363-2018 · Initiated February 23, 2018

    Recall

    Recall Number
    Z-1363-2018
    Event Number
    79498
    Firm
    Orthofix, Inc
    FEI Number
    2183449
    Product Code
    NKG
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 23, 2018
    Terminated
    June 18, 2019
    Address
    3451 Plano Pkwy, Lewisville, TX, 75056-9453

    Description

    ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003

    Reason

    Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affected Lot Numbers 002, 003 and 004. Through the company's manufacturing controls, size discrepancies were noted with the drive feature for both the large and small sets screws. As a result, it is possible that (1) the set screw drive feature will not accept the Set Screw Driver (PN: 79-1006) or (2) the driver may get wedged in the corners of the drive feature (false bottom) which may lead to a stripped set screw.

    Action

    The firm disseminated the recall notices on 02/23/2018 by mail. The firm requested the return of the screws.

    Distribution

    US

    Quantity

    397 units