BEUDAMED
    FDA Enforcement Class II Terminated

    UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral components and femoral trial, and to remove femoral trial.

    Recall: Z-1692-2017 · Reported April 5, 2017

    Enforcement

    Recall Number
    Z-1692-2017
    Event ID
    76540
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    United Orthopedic Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 5, 2017
    Initiation Date
    February 10, 2017
    Classification Date
    March 29, 2017
    Termination Date
    June 28, 2017
    Address
    No. 57 Park Avenue 2, Science Park, Hsinchu, N/A, Taiwan

    Description

    UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral components and femoral trial, and to remove femoral trial.

    Reason

    The locking lever pin component of the femoral driver may become deformed and break, resulting in malfunction during surgery and causing the device to become inoperable.

    Code Info

    Lot numbers T16A178A (17 units); T16A178B (1 unit), T16A178B1 (3 units); T16A178C (12 units)

    Distribution

    Worldwide Distribution - US including State of CA and Internationally to Pakistan, Spain, and Taiwan.

    Quantity

    33 units