BEUDAMED
    FDA Recall Terminated

    FOUNDATION HIP SYSTEM Series 460 Hip Stem STERILE R CEMENTED Sz 16.5mm DJO Surgical 9800 Metric Blvd., Austin, TX 78758 The Foundation Non-Porous Stem is intended for treatment of patients who are candidates for total or hemi-hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion and are intended to be used with bone cement.

    Recall: Z-0418-2012 · Initiated August 17, 2011

    Recall

    Recall Number
    Z-0418-2012
    Event Number
    59739
    FEI Number
    1000116912
    Product Code
    JDI
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    August 17, 2011
    Posted
    January 11, 2012
    Terminated
    May 11, 2012
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758

    Description

    FOUNDATION HIP SYSTEM Series 460 Hip Stem STERILE R CEMENTED Sz 16.5mm DJO Surgical 9800 Metric Blvd., Austin, TX 78758 The Foundation Non-Porous Stem is intended for treatment of patients who are candidates for total or hemi-hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion and are intended to be used with bone cement.

    Reason

    The sterility has the potential to be compromised.

    Action

    Encore Medical Lp sent a Urgent Field Safety Notice dated August 17, 2011. to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately quarantine these devices if you have not already done so. Contact Customer Service to obtain replacement devices as well as an RMA. Return all affected devices by October 31, 2011, using the RMA Customer Service provided in step #3. If you have any further questions you may call (512 ) 834-6330. For International Customer Service please call (512) 834-6275.

    Distribution

    Worldwide Distribution -- USA ( nationwide ) including the states of WI, NY, MO, TX, FL, CA, UT, AZ, Puerto Rico, and the country Japan.

    Quantity

    169 units