BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or replace the standard instruments used during the implantation of hip, knee, trauma and upper extremities implants

    Recall: Z-2390-2016 · Reported August 17, 2016

    Enforcement

    Recall Number
    Z-2390-2016
    Event ID
    74619
    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 17, 2016
    Initiation Date
    June 23, 2016
    Classification Date
    August 11, 2016
    Termination Date
    August 1, 2018
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2006, United States

    Description

    Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or replace the standard instruments used during the implantation of hip, knee, trauma and upper extremities implants

    Reason

    It was reported that the secondary locking mechanism, and its corresponding components, disassociated from the Specialty Triathlon Tibial Alignment Handle with Secondary Lock Assembly during surgery. Upon further investigation, it was discovered that the weld, which was intended to hold the secondary locking mechanism together, did not meet the weld size specified on the engineering drawing.

    Code Info

    Catalog No: I-K3254TA00 Lot Nos: F6E13243, F6L13864, F6M14078, F6S14667, F6S14831, F6W15444, F6W15406, F7C15943, F7H16099 and F7L16994

    Distribution

    Nationwide Distribution to FL, IN, LA, NC, PA, TN and UT

    Quantity

    47 units