BEUDAMED
    FDA Enforcement Class II Terminated

    TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 12 RIGHT, STERILE R, REF 12 000 028, S&N 7500283, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

    Recall: Z-1551-2016 · Reported April 27, 2016

    Enforcement

    Recall Number
    Z-1551-2016
    Event ID
    73609
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 27, 2016
    Initiation Date
    March 11, 2016
    Classification Date
    April 21, 2016
    Termination Date
    April 10, 2017
    Address
    1450 E Brooks Rd, N/A, Memphis, TN, 38116-1804, United States

    Description

    TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 12 RIGHT, STERILE R, REF 12 000 028, S&N 7500283, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

    Reason

    The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

    Code Info

    Batch numbers: B1509884, B1503362

    Distribution

    International Distribution only in countries of: Germany and Switzerland.

    Quantity

    6 units