BEUDAMED
    FDA Recall Terminated

    DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 64mm GROUP H, REF DSBFGH64, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular shell.

    Recall: Z-1025-2012 · Initiated January 3, 2012

    Recall

    Recall Number
    Z-1025-2012
    Event Number
    60947
    Firm
    Wright Medical Technology Inc
    FEI Number
    1043534
    Product Code
    KWA
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    January 3, 2012
    Posted
    February 14, 2012
    Terminated
    March 13, 2013
    Address
    5677 Airline Rd, Arlington, TN, 38002-9501

    Description

    DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 64mm GROUP H, REF DSBFGH64, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular shell.

    Reason

    The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery.

    Action

    Wright Medical sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated December 27, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory for the affected product and to return any affected product to the firm. A Product Recall Verification Form was enclosed for customers to complete and return via fax to 901-867-7401. Contact Customer Service at 1-800-238-7117 for questions regarding this recall.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, Denmark, and Italy.

    Quantity

    155 units