BEUDAMED
    FDA Enforcement Class II Terminated

    TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 10 LEFT, STERILE R, REF 12 000 006, S&N 7500261, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

    Recall: Z-1539-2016 · Reported April 27, 2016

    Enforcement

    Recall Number
    Z-1539-2016
    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 Left, SIZE 10 LEFT, STERILE R, REF 12 000 006, S&N 7500261, 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 number C1507675

    Distribution

    International Distribution only in countries of: Germany and Switzerland.

    Quantity

    3 units