BEUDAMED
    FDA Recall Terminated

    DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 5, Sterile, DePuy Orthopaedics. This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a femoral hip prosthesis.

    Recall: Z-1688-2011 · Initiated January 27, 2011

    Recall

    Recall Number
    Z-1688-2011
    Event Number
    57900
    Firm
    Depuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    JDK
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    January 27, 2011
    Posted
    March 17, 2011
    Terminated
    April 23, 2013
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 5, Sterile, DePuy Orthopaedics. This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a femoral hip prosthesis.

    Reason

    The firm became aware of a manufacturing error resulting in a potentially incomplete seal of the outer pouch. Although the sterility of the product is not compromised, the sterility of the inner pouch containing the product cannot be assured. Lack of sterility of the inner pouch could potentially cause contamination of the sterile field, including the implant. Non-sterile product and/or contaminat

    Action

    DePuy Orthopaedics sent an URGENT INFORMATION RECALL NOTICE dated January 27, 2011, to DePuy Area Directors, FMDs, Distributors, and Office Managers. The notice identified the product, the problem, and the action to be taken. All territories were required to ensure that all recalled products that remain in customer accounts and field inventory are returned immediately to Warsaw to the attention of Returns. Hospitals that purchased and potentially implanted the now recalled product should be provided appropriate notification of the recall and should complete and return a signed Reconciliation Form(s) within seven business days. If the hospitals have any inventory on hand that is subject to the recall, distributors should remove it or help the hospitals return it for credit. All Reconciliation Forms should be faxed to 574-372-7567. For questions regarding this recall call 574-372-7333.

    Distribution

    Nationwide distribution including the states of MA, PA, FL, LA, MN, WA, WI, CO, GA, NY, NC and SC and the countries of Canada, Colombia, Ireland and Argentina.

    Quantity

    20