BEUDAMED
    FDA Enforcement Class II Terminated

    MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, SIZE 50 REF S-200958 - 5mm PIN, SIZE 58

    Recall: Z-3102-2017 · Reported September 6, 2017

    Enforcement

    Recall Number
    Z-3102-2017
    Event ID
    77930
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Encore Medical, Lp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 6, 2017
    Initiation Date
    August 4, 2017
    Classification Date
    August 30, 2017
    Termination Date
    June 28, 2023
    Address
    9800 Metric Blvd, N/A, Austin, TX, 78758-5445, United States

    Description

    MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, SIZE 50 REF S-200958 - 5mm PIN, SIZE 58

    Reason

    It was reported that the models used to manufacture S-200956/958 had the wrong dimension used to create the spherical radius cutting surface. Device design allows a larger spherical radius cutting surface than intended.

    Code Info

    Catalog number, Lot Number S-200956, 535U1000 S-200957, 536U1000 S-200958, 537U1000

    Distribution

    OH, VA

    Quantity

    5 units