BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1363-2018 · Reported April 18, 2018

    Enforcement

    Recall Number
    Z-1363-2018
    Event ID
    79498
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Orthofix, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 18, 2018
    Initiation Date
    February 23, 2018
    Classification Date
    April 11, 2018
    Termination Date
    June 18, 2019
    Address
    3451 Plano Pkwy, Lewisville, TX, 75056-9453, United States

    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.

    Code Info

    UDI 18257200125371, Lot Numbers: O02, O03 and O04

    Distribution

    US

    Quantity

    397 units