BEUDAMED
    FDA Enforcement Class II Terminated

    P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830

    Recall: Z-2949-2018 · Reported September 5, 2018

    Enforcement

    Recall Number
    Z-2949-2018
    Event ID
    80666
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Orthopaedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 5, 2018
    Initiation Date
    July 18, 2018
    Classification Date
    August 29, 2018
    Termination Date
    April 17, 2019
    Address
    700 Orthopaedic Dr, N/A, Warsaw, IN, 46582-3994, United States

    Description

    P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830

    Reason

    This unit may be missing the screw/collet Assembly

    Code Info

    Lot: C2KJ24, GTIN: 10603295234135

    Distribution

    The devices were not distributed in the United States. The devices were distributed to the following foreign countries: Great Britain.

    Quantity

    1