BEUDAMED
    FDA Enforcement Class II Terminated

    Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.

    Recall: Z-1103-2021 · Reported February 17, 2021

    Enforcement

    Recall Number
    Z-1103-2021
    Event ID
    87189
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Orthopaedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 17, 2021
    Initiation Date
    January 8, 2021
    Classification Date
    February 9, 2021
    Termination Date
    January 17, 2024
    Address
    700 Orthopaedic Dr, N/A, Warsaw, IN, 46582-3994, United States

    Description

    Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.

    Reason

    The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.

    Code Info

    Product No.: 129453216, 129453226, 129453236,129453246 Lot No.: J85Y90, J86T23, J86T20, J8790J, J85Y92

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AK, CA, FL, IN, MI, MN, MS, NC, NY, OH, PA, TX, VA and the countries of Canada, China, Germany, Puerto Rico, Switzerland.

    Quantity

    60 sleeves