BEUDAMED
    FDA Enforcement Class II Ongoing

    Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usable instruments required for implanting the Triathlon Globalization Implant System for individual patients receiving primary total knee arthroplasty (TKA). Catalog# 6541-9-109

    Recall: Z-0459-2022 · Reported January 12, 2022

    Enforcement

    Recall Number
    Z-0459-2022
    Event ID
    89190
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 12, 2022
    Initiation Date
    November 24, 2021
    Classification Date
    January 6, 2022
    Address
    325 Corporate Dr, N/A, Mahwah, NJ, 07430-2006, United States

    Description

    Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usable instruments required for implanting the Triathlon Globalization Implant System for individual patients receiving primary total knee arthroplasty (TKA). Catalog# 6541-9-109

    Reason

    Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemented Keel Punch (P/N: 6541-2-013Y) instrument can lead to delay in surgery or if used could lead to unintended bone preparation

    Code Info

    Lots #: 0552101A596, 0552101A602 GTIN#: 07613327461503

    Distribution

    US Nationwide distribution in the states of GA, MI, NC, TX.

    Quantity

    7 units