BEUDAMED
    FDA Recall Terminated

    Zimmer Durom Hip Resurfacing Systems, Femoral Component 54 Code T; Catalog No.: 01.00211.154, Zimmer, Warsaw, IN, 46581-0708.

    Recall: Z-0275-2008 · Initiated September 26, 2007

    Recall

    Recall Number
    Z-0275-2008
    Event Number
    45326
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    KXA
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    September 26, 2007
    Posted
    November 29, 2007
    Terminated
    June 4, 2008
    Address
    345 E. Main St., Warsaw, IN, 46580-2304

    Description

    Zimmer Durom Hip Resurfacing Systems, Femoral Component 54 Code T; Catalog No.: 01.00211.154, Zimmer, Warsaw, IN, 46581-0708.

    Reason

    Mislabeled as to size; 54mm package contains 46 mm device and vice versa.

    Action

    Zimmer GmbH notified Distributors via a Product Recall Notification letter, dated 9/26/07, instructing them to return the products and to subrecall.

    Distribution

    Nationwide

    Quantity

    1