BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 (component of the Triathlon Total Knee System) for fixation to the tibial baseplates via a locking wire mechanism.

    Recall: Z-2389-2015 · Reported August 26, 2015

    Enforcement

    Recall Number
    Z-2389-2015
    Event ID
    71678
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 26, 2015
    Initiation Date
    May 29, 2015
    Classification Date
    August 14, 2015
    Termination Date
    September 26, 2016
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2006, United States

    Description

    Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 (component of the Triathlon Total Knee System) for fixation to the tibial baseplates via a locking wire mechanism.

    Reason

    Stryker has received a report which identified that a Triathlon Tibial Bearing Insert CS X3 Size #2 9mm (5531-G-209) was reported to be in a pack that was labelled as a CR insert (5530-G-209).

    Code Info

    Catalog number 5530-G-209 Lot Code LEF064

    Distribution

    OH, SC, RI, WV

    Quantity

    10 units