BEUDAMED
    FDA Enforcement Class II Terminated

    2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile

    Recall: Z-0637-2017 · Reported November 30, 2016

    Enforcement

    Recall Number
    Z-0637-2017
    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

    2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile

    Reason

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

    Code Info

    Catalog ID 351.707S, Lot Numbers: 9963694; 9963695; 9963696; 9963697; 9963698; 9963699; 9972862; H040500; H040502; H040503; H060093; H060094; H060095; H060096; H060097; H080022; H080023; H080024; H080025; H089873; H089874; H089875.

    Distribution

    Distributed Nationwide

    Quantity

    1,951 units