BEUDAMED
    FDA Enforcement Class II Terminated

    Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm Product Usage: The Triathlon PS X3 (posterior stabilized), cat no 5532-G-xxx and X3 TS (total stabilizing) Plus, cat. no. 5537-G-XXX, Tibial Inserts are used in TKA surgeries. During surgery, the tibial insert is locked into the tibial baseplate where it serves as the bearing component for the articulating surface of a corresponding Triathlon femoral component.

    Recall: Z-2360-2015 · Reported August 19, 2015

    Enforcement

    Recall Number
    Z-2360-2015
    Event ID
    71677
    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 19, 2015
    Initiation Date
    May 29, 2015
    Classification Date
    August 10, 2015
    Termination Date
    July 25, 2016
    Address
    325 Corporate Dr, N/A, Mahwah, NJ, 07430-2006, United States

    Description

    Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm Product Usage: The Triathlon PS X3 (posterior stabilized), cat no 5532-G-xxx and X3 TS (total stabilizing) Plus, cat. no. 5537-G-XXX, Tibial Inserts are used in TKA surgeries. During surgery, the tibial insert is locked into the tibial baseplate where it serves as the bearing component for the articulating surface of a corresponding Triathlon femoral component.

    Reason

    Stryker Orthopaedics received a report that 5537-G-319 No 3. Triathlon TS Plus Tibial Insert X3 Poly 19 mm i insert was in a package labeled as a 5532-G-511 Triathlon PS Stibialism Insert.

    Code Info

    Catalog Number 5532-G-511 Lot LD8D7Y Catalog Number 5537-G-319 Lot TT6JT2

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    26 units