BEUDAMED
    FDA Recall 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 · Initiated March 11, 2016

    Recall

    Recall Number
    Z-1539-2016
    Event Number
    73609
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 11, 2016
    Posted
    April 21, 2016
    Terminated
    April 10, 2017
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    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.

    Action

    The firm, Smith & Nephew, issued an "URGENT FIELD SAFETY NOTICE: Medical Device Field Safety Corrective Action/Recall" letter dated 3/10/2016 to its local QA/RA personnel/customers in the affected countries by email on 03/11/2016. The letter described the product, problem and actions to be taken. The customers were instructed to locate and quarantine affected unused devices immediately; return quarantined product to your national Smith & Nephew agency/distributor; complete and return the Return Slip via fax to your national Smith & Nephew agency/distributor; and pass on this safety information to all those who need to be aware in your organization. The local QA/RA staff will then notify end customers according to local procedures. In Germany as well as in Switzerland, sales representatives will inform the affected customers in-person and retrieve affected devices from their stock. If you have any questions, call 978-749-1330 or email: [email protected]

    Distribution

    International Distribution only in countries of: Germany and Switzerland.

    Quantity

    3 units