BEUDAMED
    FDA Recall Terminated

    ProVision Hytrel Elastomer Hood; product 5431-05-000.

    Recall: Z-1040-03 · Initiated June 27, 2003

    Recall

    Recall Number
    Z-1040-03
    Event Number
    26691
    Firm
    Depuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    FYA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 27, 2003
    Posted
    July 23, 2003
    Terminated
    February 4, 2004
    Address
    700 Orthopaedic Drive, Warsaw, IN, 46581

    Description

    ProVision Hytrel Elastomer Hood; product 5431-05-000.

    Reason

    Lack of assurance of sterility, due to the possibility of an incomplete package seal.

    Action

    An Urgent Recall Notice was sent to customers on June 27, 2003 via federal express. Customers were instructed to locate all affected inventory and to immediately return it to Depuy.

    Distribution

    United States, Australia, Canada, Chile, England, India, Japan, Malaysia, Singapore, South Africa, Taiwan and United Kingdom