BEUDAMED
    FDA Enforcement Class II Terminated

    3.0 mm Reaming Rod/950 mm, Sterile

    Recall: Z-0638-2017 · Reported November 30, 2016

    Enforcement

    Recall Number
    Z-0638-2017
    Event ID
    75502
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes (USA) Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 30, 2016
    Initiation Date
    October 3, 2016
    Classification Date
    November 19, 2016
    Termination Date
    July 6, 2017
    Address
    1301 Goshen Pkwy, N/A, West Chester, PA, 19380-5986, United States

    Description

    3.0 mm Reaming Rod/950 mm, Sterile

    Reason

    The peel pouches for the affected reaming rods and extraction hooks are delaminating.

    Code Info

    Catalog ID 351.71S, Lot Numbers: H000111; H033314; H067857; H067858; H069074; H069079; H087019; H090015; H090747; H100713; H123976.

    Distribution

    Distributed Nationwide

    Quantity

    887 units