BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 left, Sterile, Catalog # 504-02-64E-L, UDI (01)07613327012484(17)

    Recall: Z-2094-2020 · Reported May 27, 2020

    Enforcement

    Recall Number
    Z-2094-2020
    Event ID
    85583
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 27, 2020
    Initiation Date
    April 16, 2020
    Classification Date
    May 21, 2020
    Termination Date
    November 15, 2021
    Address
    325 Corporate Dr, N/A, Mahwah, NJ, 07430-2006, United States

    Description

    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 left, Sterile, Catalog # 504-02-64E-L, UDI (01)07613327012484(17)

    Reason

    The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.

    Code Info

    Lot #s Y32LP9, AN6ATN, A77J57, EE69A8, 625VEM, K8549T, EV6MXD, L85MMA, 7E2R48, M21Y21, H71N5N, A74YXL, PN2X3H, V2774X, AE6LJR, 7D0YJE, 6957YA, LM5N9M, 477ELH, JN8347, AY8T8N, EM0W77, TL29PE, NX79TH, 956DXP, A86VNH, KX5MX1, WW7VPM, 7A58DL, 37348T, N80109, 1269DY, 2351A5, H58V9W, 5M1K6H, T3509E, HL627T, WY1XP7, A76DE6, PX677J, AK4L6N, EA2MNR, AM5H8X, KM0M7W, D33PLA, 7R165A

    Distribution

    Worldwide distribution including the following states: New York, Arkansas, Oklahoma, Michigan, Delaware, Texas, Louisiana, California, Florida, Arizona, Nevada, Ohio, Colorado, Rhode Island, Iowa, Pennsylvania, Massachusetts, North Carolina, Alabama, New Hampshire, Illinois, New Jersey, Virginia, Utah, Maryland, Mississippi, Missouri, Tennessee, Connecticut, and Kansas

    Quantity

    N/A