BEUDAMED
    FDA Enforcement Class II Terminated

    DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures

    Recall: Z-2317-2017 · Reported June 14, 2017

    Enforcement

    Recall Number
    Z-2317-2017
    Event ID
    76023
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Orthopaedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 14, 2017
    Initiation Date
    January 6, 2017
    Classification Date
    June 8, 2017
    Termination Date
    May 15, 2019
    Address
    700 Orthopaedic Dr, N/A, Warsaw, IN, 46582-3994, United States

    Description

    DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures

    Reason

    Products were made outside of Quality System Regulation, and potentially outside of premarket submission (510k/PMA) for certain devices. The safety or effectiveness of these devices cannot be assured.

    Code Info

    Unknown

    Distribution

    Nationwide Distribution to: AZ CA IA IL IN LA MA MD ME MI MN PA VA

    Quantity

    345