BEUDAMED
    FDA Recall Terminated

    Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 4 3/4 inches in length. Catalog # 281-01-10.

    Recall: Z-0124-04 · Initiated October 15, 2003

    Recall

    Recall Number
    Z-0124-04
    Event Number
    27484
    Firm
    Zimmer Inc
    FEI Number
    1000220733
    Product Code
    JDW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 15, 2003
    Posted
    July 20, 2004
    Terminated
    May 20, 2004
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 4 3/4 inches in length. Catalog # 281-01-10.

    Reason

    The pin may fail because the metal used to make the pin does not meet the firm's hardness specification.

    Action

    All affected U.S. accounts were sent a letter dated October 15, 2003 by certified mail, return receipt requested. The seven foreign initial consignee accounts were notified via electronic mail. Customers were asked to return non-implanted product and to advise the implanting surgeons of the problem so that they may take appropriate action in regard to their patients.

    Distribution

    The majority of the pins were distributed within the United States. Distribution also occured in seven foreign countries; Taiwan, Canada, Japan, Korea, Belgium, Australia and Finland.