BEUDAMED
    FDA Recall Terminated

    Product 3 consists of all products under product code JDI, and same usage: Item no:781803800 12/14 UNIPOLAR FEMORAL HE 781804000 12/14 UNIPOLAR FEMORAL HE 781804100 12/14 UNIPOLAR FEMORAL HE 781804200 12/14 UNIPOLAR FEMORAL HE 781804300 12/14 UNIPOLAR FEMORAL HE 781804400 12/14 UNIPOLAR FEMORAL HE 781804500 12/14 UNIPOLAR FEMORAL HE 781804600 12/14 UNIPOLAR FEMORAL HE 781804700 12/14 UNIPOLAR FEMORAL HE 781804800 12/14 UNIPOLAR FEMORAL HE 781804900 12/14 UNIPOLAR FEMORAL HE 781805000 12/14 UNIPOLAR FEMORAL HE 781805100 12/14 UNIPOLAR FEMORAL HE 781805200 12/14 UNIPOLAR FEMORAL HE 781805300 12/14 UNIPOLAR FEMORAL HE 781805400 12/14 UNIPOLAR FEMORAL HE 781805500 12/14 UNIPOLAR FEMORAL HE 781806300 12/14 UNIPOLAR FEMORAL HE 781809900 12/14 UNIPOLAR FEMORAL HE 781809901 12/14 UNIPOLAR FEMORAL HE 781809902 12/14 UNIPOLAR FEMORAL HE Product For use in total or hemi hip arthroplasty

    Recall: Z-1101-2016 · Initiated January 11, 2016

    Recall

    Recall Number
    Z-1101-2016
    Event Number
    72900
    FEI Number
    1000132037
    Product Code
    JDI
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    January 11, 2016
    Posted
    March 12, 2016
    Terminated
    April 13, 2017
    Address
    Zimmer Manufacturing B.V. Turpeaux Industrial Park Rd 1 km 123.4, Mercedita, PR, 00715

    Description

    Product 3 consists of all products under product code JDI, and same usage: Item no:781803800 12/14 UNIPOLAR FEMORAL HE 781804000 12/14 UNIPOLAR FEMORAL HE 781804100 12/14 UNIPOLAR FEMORAL HE 781804200 12/14 UNIPOLAR FEMORAL HE 781804300 12/14 UNIPOLAR FEMORAL HE 781804400 12/14 UNIPOLAR FEMORAL HE 781804500 12/14 UNIPOLAR FEMORAL HE 781804600 12/14 UNIPOLAR FEMORAL HE 781804700 12/14 UNIPOLAR FEMORAL HE 781804800 12/14 UNIPOLAR FEMORAL HE 781804900 12/14 UNIPOLAR FEMORAL HE 781805000 12/14 UNIPOLAR FEMORAL HE 781805100 12/14 UNIPOLAR FEMORAL HE 781805200 12/14 UNIPOLAR FEMORAL HE 781805300 12/14 UNIPOLAR FEMORAL HE 781805400 12/14 UNIPOLAR FEMORAL HE 781805500 12/14 UNIPOLAR FEMORAL HE 781806300 12/14 UNIPOLAR FEMORAL HE 781809900 12/14 UNIPOLAR FEMORAL HE 781809901 12/14 UNIPOLAR FEMORAL HE 781809902 12/14 UNIPOLAR FEMORAL HE Product For use in total or hemi hip arthroplasty

    Reason

    As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

    Action

    Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to 1.Review the notification and ensure that relevant personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product. 3. Your Zimmer Biomet sales representative will remove the recalled product from your facility. 4. Complete and return the attached Certificate of Acknowledgment form to [email protected]. 5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative.

    Distribution

    US Nationwide Distribution

    Quantity

    2,239