BEUDAMED
    FDA Enforcement Class II Ongoing

    Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V Allow with HA Coating, For use with Stinson Orthopedics Inc. Total Hip Replacement System Only, CEMENTLESS, UDI: (01) 00841176102934

    Recall: Z-1568-2020 · Reported April 1, 2020

    Enforcement

    Recall Number
    Z-1568-2020
    Event ID
    85121
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Signature Orthopaedics Europe Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 1, 2020
    Initiation Date
    October 9, 2019
    Classification Date
    March 25, 2020
    Address
    Unit A, IDA Business & Technology Park, Garrycastle, Athlone, N/A, N/A, Ireland

    Description

    Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V Allow with HA Coating, For use with Stinson Orthopedics Inc. Total Hip Replacement System Only, CEMENTLESS, UDI: (01) 00841176102934

    Reason

    The firm has identified that packaging containing components of the hip replacement range are mislabeled. This could result in the product intended to be used for a procedure not included in the packaging resulting in a surgical delay.

    Code Info

    Lot # 7DD49-1

    Distribution

    US: California

    Quantity

    5 components