BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head element insertion.

    Recall: Z-0126-2016 · Reported October 21, 2015

    Enforcement

    Recall Number
    Z-0126-2016
    Event ID
    72243
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes (USA) Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 21, 2015
    Initiation Date
    September 21, 2015
    Classification Date
    October 15, 2015
    Termination Date
    August 26, 2016
    Address
    1301 Goshen Pkwy, N/A, West Chester, PA, 19380-5986, United States

    Description

    Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head element insertion.

    Reason

    Certain lots of the Screw Inserter may be etched with incorrect graphics. The orientation of the etched image of the oblique angle on the Screw Inserter may not correspond to the tip of the angle of the instrument.

    Code Info

    Part Number 03.037.025 Lot Numbers 8911887; 8911975; 9166356; 9285766; 9286671; 9319408; 9375245; 9375251; 9388359; 9388360; 9393071; 9393074; 9393075; 9393076; 9409795; 9409796; 9422892; 9422895; 9498455; 9310899; 9310900; 9319407

    Distribution

    US Nationwide Distribution

    Quantity

    793