BEUDAMED
    FDA Enforcement Class II Terminated

    2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component. Size 38/39 mm REF number 02423839 Size 42/44 mm REF number 02424244 Size 44/48 mm REF number 02424448 Size 46/52 mm REF number 02424652

    Recall: Z-2517-2018 · Reported August 1, 2018

    Enforcement

    Recall Number
    Z-2517-2018
    Event ID
    80498
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    IMPLANTCAST GMBH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 1, 2018
    Initiation Date
    December 28, 2017
    Classification Date
    July 20, 2018
    Termination Date
    September 1, 2020
    Address
    Luneburger Schanze 26, N/A, Buxtehude, N/A, N/A, Germany

    Description

    2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component. Size 38/39 mm REF number 02423839 Size 42/44 mm REF number 02424244 Size 44/48 mm REF number 02424448 Size 46/52 mm REF number 02424652

    Reason

    Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted.

    Code Info

    Article/Batch numbers: Size 38/39 mm REF number 02423839 Batch 150201G, 1504298, 1504299, 150429C, 150429L; Size 42/44 mm REF number 02424244 Batch 1702188, 15042AF, 15042A7, 15042A6, 15042A5; Size 44/48 mm REF number 02424448 Batch 1702189, 1637108, 16141C1; Size 46/52 mm REF number 02424652 Batch 1637109, 16141C2.

    Distribution

    Distribution in Europe and US states of Texas, Rhode Island and Georgia.

    Quantity

    304, 3 in US