BEUDAMED
    FDA Recall Terminated

    Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Left, Size 0, TIB B/PL, for cemented use only, sterile, Zimmer, Warsaw, IN; Model Number: 6420-00-200. The Natural-Knee II System Cemented Modular Tibial Baseplate is a nonporous component which may be used in total knee replacement surgery. The baseplate is intended for cemented use only.

    Recall: Z-1484-2009 · Initiated March 18, 2009

    Recall

    Recall Number
    Z-1484-2009
    Event Number
    51406
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 18, 2009
    Posted
    June 30, 2009
    Terminated
    October 23, 2009
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Left, Size 0, TIB B/PL, for cemented use only, sterile, Zimmer, Warsaw, IN; Model Number: 6420-00-200. The Natural-Knee II System Cemented Modular Tibial Baseplate is a nonporous component which may be used in total knee replacement surgery. The baseplate is intended for cemented use only.

    Reason

    The tibial spacer will not affix to the distal surface of the baseplate, as intended.

    Action

    Zimmer, Inc. issued an "Urgent-Device Recall" letter dated March 18, 2009 instructing users to cease using and return the affected product accompanied with a completed Inventory Return Certification form. The inventory Return Certification form should also be faxed to Zimmer, Inc. at 1-574-372-4265. Further questions should be addressed to Zimmer, Inc. at 1-800-613-6131.

    Distribution

    Worldwide Distribution - USA including states of CA, NY, MI, OH, WI, IA, MN, NJ, IL, MO, TX, LA, NC, SC, PA, AR, MS, FL, GA, AL, OK, KS, TN, CT, NM, UT, NV, ID and CO and Switzerland.

    Quantity

    834 of all products