BEUDAMED
    FDA Recall Terminated

    Porous titanium flared rim acetabular shell with three clustered holes in even sizes from 48 to 66mm, a hip prosthesis component. The lot number on the product labeling is the unique identifier of this component.

    Recall: Z-0799-06 · Initiated January 12, 2006

    Recall

    Recall Number
    Z-0799-06
    Event Number
    34416
    FEI Number
    1000116912
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 12, 2006
    Posted
    April 27, 2006
    Terminated
    July 11, 2006
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758

    Description

    Porous titanium flared rim acetabular shell with three clustered holes in even sizes from 48 to 66mm, a hip prosthesis component. The lot number on the product labeling is the unique identifier of this component.

    Reason

    Voids in the porous coating of a component used in total hip replacement surgery.

    Action

    Firm notified all sales agents by letter on January 12, 2006 with instructions to return the product. The second letters went out on January 30, 2006 to the sales associates with instructions to contact the implanting physicians.

    Distribution

    Nationwide. Iowa, Florida, California, Arizona, South Dakota, Utah, Missouri, Texas, and Massachusetts, Maryland, Oklahoma, Nevada

    Quantity

    Total of 30 units