BEUDAMED
    FDA Enforcement Class II Terminated

    3.0 mm Guide Rod/950 mm with Smooth Tip, sterile

    Recall: Z-0640-2017 · Reported November 30, 2016

    Enforcement

    Recall Number
    Z-0640-2017
    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 Guide Rod/950 mm with Smooth Tip, sterile

    Reason

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

    Code Info

    Catalog ID 355.041S, Lot Numbers: H085635; H087271; H094462; H111419; H136756

    Distribution

    Distributed Nationwide

    Quantity

    319 units