BEUDAMED
    FDA Recall 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 · Initiated September 14, 2015

    Recall

    Recall Number
    Z-0024-2016
    Event Number
    72238
    Firm
    Synthes (USA) Products LLC
    FEI Number
    3008812560
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 14, 2015
    Posted
    October 5, 2015
    Terminated
    July 15, 2016
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986

    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.

    Action

    An urgent notice of medical device recall, dated September 14, 2015, was sent to end users and sales consultants to alert them to the issue and potential risks. Return of the completed response form and the affected devide was also requested.

    Distribution

    Nationally

    Quantity

    172