BEUDAMED
    FDA Enforcement Class II Ongoing

    Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118

    Recall: Z-1263-2023 · Reported March 29, 2023

    Enforcement

    Recall Number
    Z-1263-2023
    Event ID
    91752
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DePuy Orthopaedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 29, 2023
    Initiation Date
    February 15, 2023
    Classification Date
    March 17, 2023
    Address
    700 Orthopaedic Dr, N/A, Warsaw, IN, 46582-3994, United States

    Description

    Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118

    Reason

    The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.

    Code Info

    GTIN: 10603295491095; Lot: JP6452

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand

    Quantity

    7 units