BEUDAMED
    FDA Enforcement Class II Terminated

    Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use in knee prosthesis implantation. NON-STERILE

    Recall: Z-0964-2013 · Reported March 27, 2013

    Enforcement

    Recall Number
    Z-0964-2013
    Event ID
    64456
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 27, 2013
    Initiation Date
    January 24, 2013
    Classification Date
    March 18, 2013
    Termination Date
    May 6, 2015
    Address
    325 Corporate Drive, N/A, Mahwah, NJ, 07430, United States

    Description

    Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use in knee prosthesis implantation. NON-STERILE

    Reason

    The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and the "R" and "L" markings on the Right Sizer are reversed.

    Code Info

    Catalog Number: I-K2401KF00 (note each is uniquely identified/marked as IK2401KF0L and IK2401KF0R - Left and Right). Lot Codes: AP5W52 and AP7H19.

    Distribution

    1 Branch (NJ) with one consignee (DE).

    Quantity

    4 units (total of 2 sets)