BEUDAMED
    FDA Recall Terminated

    Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2. Sterilized using irradiation, single use.

    Recall: Z-2737-2014 · Initiated September 9, 2014

    Recall

    Recall Number
    Z-2737-2014
    Event Number
    69039
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    GFC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 9, 2014
    Posted
    September 30, 2014
    Terminated
    May 5, 2015
    Address
    1800 W Center St, Warsaw, IN, 46580-2304

    Description

    Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2. Sterilized using irradiation, single use.

    Reason

    The Persona 48mm X 2.5mm Female Screw is being recalled due to potential use of the screw in cortical bone, and corresponding stripping of the 2.5mm Persona Hex Driver.

    Action

    Zimmer sent an URGENT MEDICAL DEVICE RECALL notifications dated September 9, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. Review the notification and the updated portion of the Persona surgical technique provided in Attachment 1, and ensure affected personnel are aware of the contents. 2. Locate and quarantine any affected product listed above and notify your Zimmer sales representative. 3. Your Zimmer sales representative will remove the recalled product from your facility. 4. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST.

    Distribution

    Nationwide Distribution including the states of : HI, CA, UT, NY, OH, IN, AL, FL, GA, WI, IA, MN, NE, SD, NJ, PA, ND, IL, MO, VA, MD, NC, MI, OR, WA, KS, KY, TN, WV, OK, CT, MA, ME, AZ, NM, TX, LA, ID, CO, MT, UT, NV and AK., and Internationally to Singapore, Japan, Germany and Canada.

    Quantity

    16,380 units