BEUDAMED
    FDA Recall Terminated

    NextGen Knee Gender Solutions CR-Flex Femoral Component, Precoat , Size D, Left. 00-5750-014-01 Zimmer, Inc. Warsaw, IN.

    Recall: Z-0915-2010 · Initiated January 27, 2010

    Recall

    Recall Number
    Z-0915-2010
    Event Number
    54359
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    January 27, 2010
    Posted
    March 2, 2010
    Terminated
    October 17, 2010
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    NextGen Knee Gender Solutions CR-Flex Femoral Component, Precoat , Size D, Left. 00-5750-014-01 Zimmer, Inc. Warsaw, IN.

    Reason

    The package should contain the left knee component but actually contains the right knee component. Delay in completing surgery may result, and a new or different implant may need to be identified.

    Action

    The firm sent an immediate notification by e-mail to all first consignees on 1/12/2010. They sent a formal recall notification on 1/27/2010. Customers should contact their Zimmer Sales representative with additional questions.

    Distribution

    US and Korea.

    Quantity

    14 units