BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates

    Recall: Z-0024-2016 · Reported October 14, 2015

    Enforcement

    Recall Number
    Z-0024-2016
    Event ID
    72238
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes (USA) Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 14, 2015
    Initiation Date
    September 14, 2015
    Classification Date
    October 5, 2015
    Termination Date
    July 15, 2016
    Address
    1301 Goshen Pkwy, N/A, West Chester, PA, 19380-5986, United States

    Description

    Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates

    Reason

    Affected lots of Periarticular Aiming Arms and Insertion Handles (Part Numbers 03.120.001, 03.120.002, 03.120.004 and 03.120.005) for the 4.5 mm LCP Proximal Tibia Plates are not able to be secured to the subsequent versions of these devices as intended.

    Code Info

    Part Numbers: 03.120.005 03.120.004 03.120.002 03.120.001 with Lot Numbers: 1780076; 1797331; 1829300 1789754; 1802319; 1810706; 1810707; 5704446 1780074; 1829294; 1829296 1789751; 1802318; 1810704; 1810705; 1828749; 1879604

    Distribution

    Nationally

    Quantity

    172