BEUDAMED
    FDA Recall Terminated

    Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.

    Recall: Z-1917-2016 · Initiated May 11, 2016

    Recall

    Recall Number
    Z-1917-2016
    Event Number
    74148
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1000220733
    Product Code
    MBH
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    May 11, 2016
    Posted
    June 7, 2016
    Terminated
    June 2, 2017
    Address
    1800 W Center St, Warsaw, IN, 46580-2304

    Description

    Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.

    Reason

    Zimmer Inc. is initiating a recall of specific Persona" Trabecular Metal" Tibial Plate Instruments and Modular Brackets, due to incidents of radiolucent lines and loosening in implants.

    Action

    Zimmer Inc. is initiating a voluntary recall of Persona" Trabecular Metal" Tibia / Tibial Plate Instruments and Modular Brackets following an increase in complaints of radiolucent lines and loosening, and earlier recall of the Persona" Trabecular Metal" Tibial Plates . All sizes and lots of the affected devices are being removed from distribution. Recall notices were issued to affected distributors, hospitals, and surgeons on 05/11/2015 via mail. Customers may contact the following with any questions: 1-877-946- 2761 between 8:00 am and 5:00pm EST. Customers are asked to do the following: 1. Review the notification and ensure affected personnel are aware of the contents. 2. Assist Zimmer Biomet sales representative with the quarantine of any affected product. 3. Zimmer Biomet sales representative will remove the recalled product from customer facilities. 4. Complete the Certificate of Acknowledgement Form and return to: [email protected].

    Distribution

    Worldwide Distribution -- US, including the states of AK, AL, AZ, CA, FL, GA, HI, ID, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WI; Foreign: Australia, New Zealand, Korea, Austria, Belgium, Germany, Italy, France, Luxembourg, Netherlands, South Africa, Spain, Sweden, Switzerland, and United Arab Emirates.

    Quantity

    10,256