BEUDAMED
    FDA Enforcement Class II Terminated

    Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100

    Recall: Z-0919-2013 · Reported March 20, 2013

    Enforcement

    Recall Number
    Z-0919-2013
    Event ID
    64306
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 20, 2013
    Initiation Date
    December 20, 2012
    Classification Date
    March 8, 2013
    Termination Date
    September 30, 2015
    Address
    325 Corporate Drive, N/A, Mahwah, NJ, 07430, United States

    Description

    Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100

    Reason

    Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use.

    Code Info

    Catalog Number: 6266-0-100 Lot Code: RD6W017, RD7L234X, RD7L234, RD7L235, RD5T305A, RD6W017J, RD6W017A, RD5T307, RD5T305T, RD5T305M, RD5T305L, RD5T306X, RD5T305, RD5T306

    Distribution

    Nationwide Distribution.

    Quantity

    48 units