BEUDAMED
    FDA Recall Terminated

    Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, used in dental and/or surgical procedures. Endobon Xenograft Granules, Bone Grafting Material, Synthetic are used in the following dental and/or surgical procedures: " Alveolar ridge augmentation/reconstruction, " Sinus elevation, " Filling of resection defects in benign bone tumor, bone cysts, or other defects in the alveolar ridge or wall, " Filling of bone defects after apicectomy, " Filling alveoli after tooth extraction. This product should not be used in non-peridontal mandibular applications.

    Recall: Z-0788-2016 · Initiated January 21, 2016

    Recall

    Recall Number
    Z-0788-2016
    Event Number
    73141
    Firm
    Biomet France SARL Plateau de Lautagne Valence Cedex
    FEI Number
    3006946279
    Product Code
    LYC
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    January 21, 2016
    Posted
    February 9, 2016
    Terminated
    May 31, 2017
    Address
    9 France

    Description

    Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, used in dental and/or surgical procedures. Endobon Xenograft Granules, Bone Grafting Material, Synthetic are used in the following dental and/or surgical procedures: " Alveolar ridge augmentation/reconstruction, " Sinus elevation, " Filling of resection defects in benign bone tumor, bone cysts, or other defects in the alveolar ridge or wall, " Filling of bone defects after apicectomy, " Filling alveoli after tooth extraction. This product should not be used in non-peridontal mandibular applications.

    Reason

    Cytotoxicity tests were not passed at 36 months. Use of Endobon-Xenograft Granules past 18 months of its specified shelf life may result in patient illness/injury.

    Action

    Zimmer BIOMET France SARL has initiated a voluntary recall via certified mail on January 2, /2016 for the Endobon Xenograft Granules, based on limited (in vitro/bench) results which indicated cytotoxicity tests were not passed at 36 months (real-time) aging. Use of the Endobon Xenograft Granules may result in patient may experiencing soft tissue irritation, up to and including infection. Customers area asked to do the following: 1. Please review this notice. 2. Identify, remove from service and segregate all affected Endobon ROX* product in your inventory. 3. Complete the attached Business Reply Form (Attachment 1) and: a. Fax it to 877-650-0368 or email it to [email protected]. 4. If you have product to return, contact BIOMET 3i at the number on the Business Reply Form for an RMA number and return shipping label. a. Return a copy of the Business Reply Form along with any affected product to the address on the Business Reply Form. Replacement product will immediately ship based upon availability. For assistance or other questions that customers may have relative to this notice, please contact BIOMET 3i at 1-800-443-8166 or 1-561-776-6700. Team members are available to assist you 8:00am to 6:00pm (Eastern), Monday through Friday.

    Distribution

    Worldwide Distribution - US including AL, AK, AR, AK, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, MI, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to Canada, Japan, Europe.

    Quantity

    145,116 units